Myconafine 250 mg. 28 tablets

ACTAVIS
Myconafine 250 mg. 28 tablets
€ 23.00
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What is Myconafine and what it is used
Myconafine tablets contain the active substance terbinafine, which relates to synthetic antifungals (antimycotics). Its effect is due to inhibition of enzymes that play a key role in the formation of important fungal substances.
Myconafine used for the treatment of fungal diseases of the skin, scalp and nails.

2. What you need to know before you take Myconafine
Do not use Myconafine if you are hypersensitive (allergic) to terbinafine or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions
Talk to your doctor or pharmacist before taking Myconafine if:
suffer from acute or chronic liver disease;
kidney impairment;
have blood disorders;
suffer from psoriasis;
you erythematosus (lupus erythematosus).
Be sure to tell your doctor if during the treatment with tablets Myconafine feel inexplicable and constant nausea, have decreased appetite, feel pain, vomit, have pain in the upper abdomen or you yellow, your urine is dark or your stools have become bright . If you have these symptoms should stop taking terbinafine. Your doctor will do tests to check how your liver.
If a skin rash that spreads quickly should discontinue the treatment and inform your doctor.
If while taking Myconafine tablets appear fever or throat become inflamed, please tell your doctor. May be necessary to conduct some blood tests.

Children and adolescents
Myconafine not be used in children under the age of 2 years.

Other medicines and Myconafine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Rifampicin (for tuberculosis);
Cimetidine (anti-ulcer);
Antidepressants, including tricyclic antidepressants (e. Dizipramin, insidon), SSRls (inhibitors of serotonin reuptake, as citalopram, fluoxetine, sertraline) or MAOI (monoamine oxidase inhibitors such as moclobemide);
Contraceptives, which are taken by mouth;
Beta-blockers (propranolol, metoprolol);
Warfarin (blood thinning);
Medicines to treat heart problems, such as arrhythmias (eg. Propafenone, amiodarone);
Cyclosporin, a drug that is used to control the body's immune system in order to prevent rejection of transplanted organs;
Other medications used to treat fungal infections (eg. Fluconazole, ketoconazole);
Medicines used for the treatment of cough (dextromethorphan);
Caffeine.
Myconafine with food, drinks and alcohol
No evidence of the need for special diets or restrictions on certain types of foods and beverages during treatment with this product.

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.

Pregnancy
If you are pregnant you should not take Myconafine unless your doctor considers it absolutely necessary.

Breastfeeding
Myconafine not be used during breastfeeding. If treatment with terbinafine nursing be discontinued before treatment.

Fertility
In studies carried out on animals no evidence of adverse effects on the fetus or impaired fertility.

Driving and using machines
No studies on the effects of treatment with terbinafine tablets on the ability to drive and use machines. Patients who experience dizziness as an undesirable effect should avoid driving or operating machinery.

3. How to take Myconafine
Always take Myconafine tablets exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist.

Dosage
Dosage is determined for each patient individually depending on the diagnosis and severity of the infection, the duration of treatment ranged from 2 weeks to 6 months.

The usual dose is:
Adults: one tablet of 250 mg or 2 tablets of 125 mg once daily.
Children: Not recommended for use Myconafine in children under 2 years of age (<12 kg).
Children weighing less than 20 kg: in 62,5 mg once daily (half a tablet of 125 mg).
Children weighing 20 to 40 kg: 125 mg once daily (1 tablet of 125 mg, or 1/2 tablet of 250 mg).
Children weighing more than 40 kg: 250 mg once daily (1 tablet of 250 mg or 2 tablets of 125 mg).

Duration of treatment:
Upon infection of the feet (including between the toes), the large skin folds in the skin of the chest and abdomen - the treatment is continued for 2 to 6 weeks;
Cutaneous candidiasis - 2 to 4 weeks;
Upon infection of the nails of hands and feet (onychomycosis) - from 6 weeks to 3 months;
In infections of the scalp - 4 weeks.
If the infection affects the toes or slow growth of the nail (in the elderly), the treatment can last 6 months. The effect of the drug lasts for several weeks after cessation of treatment.

Elderly: no need for change in dosage.

Patients with hepatic impairment: the use of Myconafine not recommended in patients with acute or chronic liver disease.

Patients with renal impairment: the use of Myconafine not recommended.

Method of administration
The tablets are taken orally with a glass of water without chewing, independent of food intake.

If you take more dose Myconafine
If you think you have taken more than the prescribed dose Myconafine, please tell your doctor. He will decide what measures to take if necessary.
Symptoms of overdose may be headache, nausea, pain in the abdomen, vomiting.

If you forget to take Myconafine
In case you miss a dose, do not take double to make up for a missed dose. Take your next dose at the usual time.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Myconafine can cause side effects, although not everybody gets them.
Typically terbinafine is well tolerated. Adverse drug reactions were mild to moderate, self-limiting with continued therapy.

Some side effects can be serious. Stop taking the tablets and tell your doctor immediately if you notice any of the following symptoms:
Yellowing of the skin or eyes. Unusually dark urine or pale stools, unexplained and constant nausea, indigestion, loss of appetite or unusual tiredness or weakness (which may be signs of liver damage);
Severe skin reactions including rash, sensitivity to light, blisters or hives;
Weakness, unusual bleeding, bruising, unusually pale skin, unusual tiredness or shortness of breath on exertion, frequent infections (this may be signs of a blood disorder);
Difficulty breathing, dizziness, swelling mainly of the face and throat, redness, elastic pain in the abdomen, stiffness, rash, fever or swollen / enlarged lymph nodes (possible signs of severe allergic reactions);
Symptoms such as rash, fever, pruritus, fatigue, or occurrence of subcutaneous purple spots (signs of inflammation of blood vessels);
Severe pain in the upper abdomen that spreads to the back (signs of inflammation of the pancreas (pancreatic));
Unexplained muscle weakness or pain, or dark (red-brown) urine (possible signs of muscle breakdown).
The frequency of side effects is as follows:
Very common: may affect more than 1 in 10 patients:
Decreased appetite;
Feeling bloated stomach, indigestion, nausea, pain in the abdomen, diarrhea;
Rash, urticaria;
Pain in joints and muscles.
Common: may affect up to 1 in 10 patients:
headache.
Uncommon: may affect up to 1 in 100 patients:
Decreased taste sensitivity or loss of taste. The taste is restored several weeks after treatment discontinuation. In isolated cases, loss of taste is long.
Very rare: may affect up to 1 in 10,000 patients:
Decreased number of white blood cells, platelets or all blood cells;
Severe allergic reactions;
Cutaneous or systemic lupus erythematosus (erythematosus);
Dizziness, numbness and tingling, decreased skin sensitivity;
Severe skin reactions such as Stevens-Johnson, toxic epidermal necrolysis, acute generalized exanthematous pustulosis;
Exacerbation of psoriasis or onset of psoriasiform skin changes;
Hair loss;
Fatigue.
Not known: frequency can not be estimated from available data:
Anemia (decreased number of red blood cells which can lead to pallor, weakness, or shortness of breath);
Allergic reactions similar to those characteristic of serum sickness;
Anxiety, depression, which are due to impaired perception of taste;
Loss of smell;
Hearing loss, hearing impaired, tinnitus;
Inflammation of blood vessels;
Inflammation of the pancreas;
Hepatitis, jaundice, stagnation of bile juices;
Photosensitivity fotodermatoza allergic reactions to light;
Muscle breakdown (rhabdomyolysis)
Influenza-like illness, fever;
Increased levels of the enzyme creatine phosphokinase;
Reduced weight (due to decreased taste sensitivity or loss of taste).
If you get any side effects, tell your doctor or pharmacist. This includes any possible effects not listed in this leaflet.

5. How to store Myconafine
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Myconafine not use after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information
What Myconafine
The active substance is terbinafine hydrochloride (terbinafine hydrochloride), eq. terbinafine / terbinafine / 125 mg or 250 mg.
Other ingredients are: cellulose, microcrystalline; croscarmellose sodium; silica colloidal anhydrous; hypromellose; magnesium stearate.

Myconafine looks like and contents of the pack
Description
Myconafine 125 mg - white, round, flat tablets, scored on both sides and 9 mm in diameter, marked "T" above the line on one side. The tablet can be divided into two equal doses.

Myconafine 250 mg - white, round, flat tablets, scored on both sides and 11 mm in diameter, marked "T" above the line and "1" below the line on one side. The tablet can be divided into two equal doses.

Package
Myconafine tablets 125 mg 10 pieces in blister AL / PVC-PVdC foil, 3 blisters (30 tablets) in a box.
Myconafine tablets of 125 mg of 14 pieces in blister AL / PVC-PVdC foil 1 blister (14 tablets) or 2 blisters (28 tablets) in a box.
Myconafine tablets 250 mg 10 pieces in blister AL / PVC-PVdC foil, 3 blisters (30 tablets) in a box.
Myconafine tablets 250 mg 14 pieces in blister AL / PVC-PVdC foil 1 blister (14 tablets) or 2 blisters (28 tablets) in a box.
€ 23.00
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