Amiodaron HCl Merck may be available in the countries listed below.
Amiodarone hydrochloride (a derivative of Amiodarone) is reported as an ingredient of Amiodaron HCl Merck in the following countries:
International Drug Name Search
Lemsip Max All in One Lemon
Powder for Oral Solution
Each sachet (4.8g) of this product contains:
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For full list of excipients, see Section 6.1.
Powder for oral solution
Pale yellow powder.
For the relief of symptoms of colds and influenza, including the relief of aches and pains, sore throat, headache, nasal congestion, lowering of temperature and chesty coughs.
Oral administration after dissolution in water.
Adults and adolescents 12 years and over: One sachet dissolved by stirring in hot water and sweetened to taste.
Dose may be repeated in 4-6 hours. No more than four doses should be taken in 24 hours.
Not to be given in children under 12 without medical advice.
Hypersensitivity to any of the ingredients.
Severe coronary heart disease.
Hypertension.
Concurrent use of monoamine oxidase inhibitors (MAOI).
Paracetamol
Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Phenylephrine
Use with caution in patients with Raynaud's phenomenon or diabetes mellitus
Phenylephrine should be used with care in patients with hyperthyroidism, cardiovascular disease, diabetes mellitus, closed angle glaucoma, prostatic enlargement and hypertension.
Sucrose
This product also contains 1973.3mg sucrose per dose (total sugars 2g). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Sodium
This product contains 129.0mg (5.6mmol) sodium per dose – to be taken into consideration for patients on a controlled sodium diet.
The following warnings will appear on the package label and/or leaflet:
• Contains a source of phenylalanine. May be harmful for people with phenylketonuria.
• Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
• DO NOT EXCEED THE STATED DOSE.
• CONTAINS PARACETAMOL. Do not take with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well.
• Keep out of the reach and sight of children.
• If symptoms persist, consult your doctor.
• DO NOT TAKE IF: allergic to any of the ingredients, if you have heart disease or high blood pressure.
• Do not store above 25oC.
• Store in the original package.
• This medicinal product contains 129.0mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet.
• If you are pregnant or are being prescribed medicine by your doctor, seek his advice before taking this product.
• Also contains aspartame, sucrose and sodium.
The rate of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Phenylephrine may adversely interact with other sympathomimetics, vasodilators and beta-blockers. Drugs, which induce hepatic microsomal enzymes, such as alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdosage. Not recommended for patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors.
Guaifenesin may increase the rate of absorption of paracetamol. Guaifenesin may interfere with diagnostic measurements of urinary 5-hydroxyindoleactic acid or vanillylmandelic acid.
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available published data do not contraindicate breast-feeding.
Phenylephrine hydrochloride: Due to the vasoconstrictive properties of phenylephrine, the product should be used with caution in patients with a history of pre-eclampsia. Phenylephrine may reduce placental perfusion and the product should be used in pregnancy only if the benefits outweigh this risk. There is no information on use in lactation.
Guaifenesin: Has been linked with an increased risk of neural tube defects in a small number of women with febrile illness in the first trimester of pregnancy. The product should be used in pregnancy only if the benefits outweigh this risk. There is no information on use in lactation.
Lemsip Max Cold & Flu Breathe Easy has no or negligible influence on ability to drive or use machinery.
Adverse effects of paracetamol are rare, but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
Phenylephrine hydrochloride: High blood pressure with headache, vomiting and rarely, palpitations. Also, rare reports of allergic reactions.
Guaifenesin has occasionally been reported to cause gastro-intestinal discomfort, nausea and vomiting, particularly in very high doses.
Paracetamol: Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk Factors
If the patient:
(a) Is on long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes, or
(b) Regularly consumes ethanol in excess of recommended amounts, or
(c) Is likely to be glutathione deplete, e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.
Phenylephrine hydrochloride: Features of severe overdosage of phenylephrine include haemodynamic changes and cardiovascular collapse with respiratory depression. Treatment includes early gastric lavage and symptomatic and supportive measures. Hypertensive effects may be treated with an i.v. alpha-receptor-blocking agent.
Guaifenesin: Very large doses may cause nausea and vomiting. The drug is, however, rapidly metabolised and excreted in the urine. Patients should be kept under observation and treated symptomatically.
ATC Code: N02B E51.
Paracetamol: Paracetamol has both analgesic and antipyretic activity, which is believed to be mediated principally through its inhibition of prostaglandin synthesis within the central nervous system.
Phenylephrine hydrochloride: Phenylephrine is a post-synaptic alpha-receptor agonist with low cardioselective beta-receptor affinity and minimal central stimulant activity. It is a recognised decongestant and acts by vasoconstriction to reduce oedema and nasal swelling.
Guaifenesin: Guaifenesin is an expectorant which reduces the viscosity of tenacious sputum.
The active ingredients are not known to cause sedation.
Paracetamol: Paracetamol is absorbed rapidly and completely from the small intestine, producing peak plasma levels after 15-20 minutes following oral dosing. The systemic availability is subject to first-pass metabolism and varies with dose between 70% and 90%. The drug is rapidly and widely distributed throughout the body and is eliminated from plasma with a T½ of approximately 2 hours. The major metabolites are glucuronide and sulphate conjugates (>80%) which are excreted in urine.
Phenylephrine hydrochloride: Phenylephrine is absorbed from the gastrointestinal tract, but has reduced bioavailability by the oral route due to first-pass metabolism. It retains activity as a nasal decongestant when given orally, the drug distributing through the systemic circulation to the vascular bed of the nasal mucosa. When taken by mouth as a nasal decongestant phenylephrine is usually given at intervals of 4-6 hours.
Guaifenesin: Guaifenesin is absorbed from the gastrointestinal tract. It is rapidly metabolised by oxidation to ί-(2 methoxy-phenoxy) lactic acid; which is excreted in the urine.
There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.
Ascorbic acid
Sucrose
Citric acid
Sodium citrate
Lemon flavour no. 1
Aspartame (E951)
Saccharin sodium
Curcumin WD
None known.
Two years
Do not store above 25°C. Store in the original package.
Heat-sealed sachet of paper/polyethylene / aluminium foil/polyethylene laminate in an outer cardboard carton.
Carton of 16 sachets.
Not applicable.
Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, East Yorkshire, UK.
PL 00063/0537
13/10/2009
26/04/2011
Cytropil may be available in the countries listed below.
Piracetam is reported as an ingredient of Cytropil in the following countries:
International Drug Name Search
Treating disorders associated with high levels of the hormone prolactin, either due to tumors in the pituitary gland or to unknown causes. It may also be used for other conditions as determined by your doctor.
Cabergoline is a dopamine receptor agonist. It works by blocking prolactin secretion from the pituitary gland.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Cabergoline. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Cabergoline. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Cabergoline may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Cabergoline as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Cabergoline.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; dizziness; headache; indigestion; mild stomach pain; nausea; tiredness or weakness; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; behavior changes (eg, aggression, increased gambling or sexual urges); burning, numbness, or tingling; chest pain; confusion; decreased urination; fainting; hallucinations; irregular heartbeat; mood or mental changes (eg, depression); persistent cough; severe or persistent dizziness or light-headedness; severe stomach pain or tenderness; shortness of breath; sudden, unexplained weight gain; swelling of hands, ankles, legs, or feet; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Cabergoline side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; hallucinations; nasal congestion.
Store Cabergoline at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cabergoline out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Cabergoline. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Relieving congestion, sneezing, and watery eyes due to colds, flu, or hay fever.
Carboxine 12D Suspension is an antihistamine and decongestant combination. It works by blocking the action of histamine and reducing the symptoms of an allergic reaction. It also relieves nasal congestion by causing vasoconstriction and shrinkage of the nasal mucous membranes and promoting drainage.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Carboxine 12D Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Carboxine 12D Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Carboxine 12D Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Carboxine 12D Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Carboxine 12D Suspension.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome: Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Appetite loss; diarrhea; dizziness; drowsiness; dry mouth, throat, or nose; headache; heartburn; nausea; nervousness; trouble sleeping; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficulty urinating; double vision or other vision problems; fast or irregular heartbeat; frequent or painful urination; hallucinations; seizures; severe headache and dizziness; severe nervousness; tremor; weakness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Carboxine2D side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased mental alertness; fast or irregular heartbeat; fever; hallucinations; nausea; seizures; sleeplessness; sweating; trouble breathing; unusual drowsiness or dizziness; tremors; vomiting.
Store Carboxine 12D Suspension at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Carboxine 12D Suspension out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Carboxine 12D Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Generic Name: colistimethate (koe LIS ti METH ate)
Brand Names: Coly Mycin M
Colistimethate is an antibiotic that fights bacteria in the body.
Colistimethate is used to treat infections caused by bacteria.
Colistimethate may also be used for purposes not listed in this medication guide.
Before using colistimethate, tell your doctor if you are allergic to any drugs, or if you have kidney disease. You may need a dose adjustment or special tests during treatment.
Colistimethate is given as an injection into a muscle or through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
Keep using colistimethate for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Colistimethate will not treat a viral infection such as the common cold or flu.
Before using colistimethate, tell your doctor if you are allergic to any drugs, or if you have kidney disease. You may need dose adjustments or special tests during treatment.
Your doctor will tell you if any of your medication doses need to be changed.
Colistimethate is given as an injection into a muscle or through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
The colistimethate injection is sometimes given every 12 hours. The medication can also be mixed with a liquid in an IV bag and given as a slow infusion over a 24-hour period.
Use each disposable needle and syringe only one time. Throw away used needles and syringes in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
Use this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
Keep using colistimethate for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Colistimethate will not treat a viral infection such as the common cold or flu.
Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.
Overdose symptoms may include confusion, dizziness, loss of balance or coordination, blurred vision, slurred speech, severe numbness or tingling, or trouble breathing.
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.
diarrhea that is watery or bloody;
fever;
urinating less than usual or not at all;
muscle weakness; or
trouble breathing.
Less serious side effects may include:
mild numbness or tingling in your hands or feet;
dizziness, spinning feeling;
itching, mild skin rash; or
upset stomach.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Gram Negative Infection:
Parenteral: 2.5 to 5 mg/kg/day IM or IV in 2 to 4 divided doses
Inhalation: 50 to 75 mg in normal saline (3 to 4 mL total volume) via nebulizer 2 to 3 times a day has been suggested
Usual Pediatric Dose for Gram Negative Infection:
Parenteral: 2.5 to 5 mg/kg/day IM or IV in 2 to 4 divided doses
Inhalation:
Neonates: 4 mg/kg/dose every 12 hours has been used to treat ventilator-associated pneumonia
Infants, children, adolescents: 50 to 75 mg in normal saline (3 to 4 mL total volume) via nebulizer 2 to 3 times a day has been suggested
The following antibiotics can interact with colistimethate. Tell your doctor if you are using any of these:
amikacin (Amikin);
gentamicin (Garamycin);
kanamycin (Kantrex);
neomycin (Mycifradin, Neo-Fradin, Neo-Tab);
netilmicin (Netromycin);
polymyxin;
streptomycin; or
tobramycin (Nebcin, Tobi).
This list is not complete and there may be other drugs that can interact with colistimethate. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
See also: colistimethate side effects (in more detail)
Generic Name: estradiol and norethindrone (topical patches) (ess tra DYE all and nor ETH in drone)
Brand Names: Combipatch
Estradiol is a form of estrogen. Estrogen is a female sex hormone that is involved in the development and maintenance of the female reproductive system.
Norethindrone is a form of progesterone. Progesterone is a female hormone important for the regulation of ovulation and menstruation.
Together, estradiol and norethindrone are used to treat the symptoms of menopause such as feelings of warmth in the face, neck and chest, or sudden intense spells of heat and sweating ("hot flashes" or "hot flushes"); to treat vulvar and vaginal changes (itching, burning, dryness in or around the vagina, difficulty or burning with urination) caused by menopause; and to replace estrogen in conditions such as hypogonadism, removal of the ovaries, or primary ovarian failure that result in a lack of estrogen.
Estradiol and norethindrone may also be used for purposes other than those listed in this medication guide.
Estradiol increases the risk of developing endometrial hyperplasia, a condition that may lead to cancer of the lining of the uterus. Using a progestin, such as norethindrone, with estradiol lowers the risk of developing this condition. Visit your doctor regularly and report any unusual vaginal bleeding right away.
Treatment with estrogens long-term may increase the risk of heart attack, stroke, breast cancer, and blood clots in the lungs or legs. Because of these risks, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before using estradiol and norethindrone long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.
Have yearly physical exams and examine your breasts for lumps on a monthly basis while using estradiol and norethindrone.
a circulation, bleeding, or blood-clotting disorder;
undiagnosed, abnormal vaginal bleeding; or
any type of breast, uterine, or hormone-dependent cancer. or
Using estradiol and norethindrone may be dangerous in some cases if you have any of the conditions listed above.
Before using estradiol and norethindrone, tell your doctor if you have
high blood pressure, angina, or heart disease;
high levels of cholesterol or triglycerides in your blood;
asthma;
epilepsy;
migraines;
depression;
diabetes;
gallbladder disease;
uterine fibroids; or
had a hysterectomy (uterus removed).
You may not be able to use estradiol and norethindrone, or you may need a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Use estradiol and norethindrone exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
To use estradiol and norethindrone patches:
Apply each patch to a smooth (fold free), clean, dry area on your lower abdomen. The area should not be oily, damaged, or irritated.
After opening a pouch, remove one side of the protective liner, taking care not to touch the adhesive part with your fingers. Immediately apply the patch. Remove the second side of the protective liner and press the patch firmly in place with your hand for at least 10 seconds, making sure there is good contact, especially around the edges.
Replace the patch on the same two days each week (every 3 to 4 days) as directed by your doctor. Only one patch should be worn at any time.
Allow at least 1 week to pass between applications of the patch to a given area.
Take care so the patch does not come off during bathing or other activities. If a patch falls off for any reason, reapply it to another site on your lower abdomen. If it will not stick, apply a new patch to a new site. Continue changing the patch on your regular schedule.
Removal of the patch should be done carefully and slowly to avoid irritation of the skin. If any adhesive remains on the skin, allow it to dry for 15 minutes. Then gently rub the area with an oil-based cream or lotion.
Your doctor may prescribe two different patches for you. In this treatment regimen, use the estrogen-only patch for the first 14 days of a 28-day cycle, according to the product directions. Then, use the estradiol and norethindrone patches for the remaining 14 days, according to the product directions. Follow your doctor's instructions or ask your pharmacist for help if you do not remember. Monthly withdrawal bleeding often occurs with this regimen.
Have yearly physical exams and examine your breasts for lumps on a monthly basis while using estradiol and norethindrone.
Apply the next patch as soon as you remember. Continue to follow your regular schedule for changing the patch. Do not use two patches simultaneously unless your doctor directs otherwise.
If a patch falls off for any reason, reapply it to another site on your lower abdomen. If it will not stick, apply a new patch to a new site. Continue changing the patch on your regular schedule.
Symptoms of a estradiol and norethindrone overdose may include nausea, vomiting, and withdrawal bleeding may occur in females.
There are no restrictions on food, beverages, or activity while using estradiol and norethindrone unless your doctor directs otherwise.
Treatment with estrogens long-term may increase the risk of heart attack, stroke, breast cancer, and blood clots in the lungs or legs. Because of these risks, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before using estradiol and norethindrone long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.
an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
sharp chest pain, coughing of blood or shortness of breath (possible blood clot in the lung );
pain in the calf (possible blood clot in the leg);
crushing chest pain or heaviness in the chest (possible heart attack);
sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (possible stroke);
partial or complete loss of vision (possible clot in the eye);
stomach pain or tenderness, yellowing of the skin or eyes, fever, fatigue, loss of appetite, dark-colored urine, or light-colored stools (possible liver problems); or
new or changing breast lumps.
Other, less serious side effects may be more likely to occur. Continue to use estradiol and norethindrone and talk to your doctor if you experience
nausea and vomiting;
tenderness or enlargement of the breasts;
weakness;
swelling of the hands or feet;
spotty darkening of the skin, particularly on the face;
difficulty in wearing contact lenses;
vaginal irritation or discomfort;
a rash or reaction at the patch application site; or
changes in menstrual cycle, painful menstruation, or breakthrough bleeding.
Estradiol increases the risk of developing endometrial hyperplasia, a condition that may lead to cancer of the lining of the uterus. Using a progestin, such as norethindrone, with estradiol lowers the risk of developing this condition. Visit your doctor regularly and report any unusual vaginal bleeding right away.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Before using estradiol and norethindrone, tell your doctor if you are taking an anticoagulant (blood thinner) such as warfarin (Coumadin). You may not be able to use estradiol and norethindrone, or you may require a dosage adjustment or special monitoring during treatment if you are taking warfarin (Coumadin).
Drugs other than those listed here may also interact with estradiol and norethindrone. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.
See also: Combipatch side effects (in more detail)
