500 film-coated tablets 
tinidazole

1. What Fasigyn is and what it is used for

Fasigyn contains a substance called tinidazole that kills certain bacteria and protozoa(unicellular organisms ) without damaging human tissue.

Fasigyn is used in the treatment of infections caused by certain bacteria or protozoa, e.g. Trichomonas vaginalis. These infections can occur in the intestines as well as in the genitals of both men and women.

Tinidazole contained in Fasigyn may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Fasigyn

Do not use Fasigyn

  • if you are allergic to tinidazole, other 5-nitroimidazole derivatives, or any of the other ingredients of this medicine (listed in section 6).
  • in certain disease states of the central nervous system
  • in case of a certain pathological change of the blood (blood dyscrasia )
  • during the first three months of pregnancy (first trimester) or if you are trying to conceive (see section Pregnancy, breast-feeding, and fertility ).

Warnings and cautions

Contact a doctor if, after taking Fasigyn, you should feel any neurological changes such as dizziness, inability to coordinate movements ( ataxia ), impaired function in peripheral nerves (may, for example, affect sensation or muscle function), or seizures.

Children and young people

Fasigyn is not recommended for children under 12 years.

Other drugs and Fasigyn

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Concomitant use of blood-thinning medicines (eg warfarin ) may be affected by treatment with Fasigyn.

Fasigyn with food, drink, and alcohol

Fasigyn should if possible be taken in conjunction with, or shortly after a meal.

Alcohol consumption should be avoided. If alcohol is consumed during treatment and up to 3 days (72 hours) after treatment, it can cause several unpleasant symptoms, e.g. redness, abdominal cramps, vomiting, and palpitations.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Fasigyn should not be used during the first three months of pregnancy (first trimester). It should only be used during the last six months of pregnancy (the second and third trimesters) if your doctor deems it necessary.

The active substance tinidazole is excreted in human milk. Children who are breastfed may be affected. You should not breast-feed while taking Fasigyn and for at least 3 days after stopping treatment.

Driving and using machines

No studies have been performed, but to date, there is no evidence that Fasigyn affects the ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these

effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Fasigyn contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to use Fasigyn

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dose one is determined by the doctor, who adjusts it individually for you. The size of the dose and the duration of treatment are different depending on the infection being treated. After just a few days, the symptoms may subside. However, the entire course must be completed. Otherwise, there is a risk that infection will return.

Infection of Trichomonas vaginalis in the vagina in women is usually treated with a single dose. The sexual partner is also treated, as he or she can be infected without having any symptoms.

Fasigyn should if possible be taken in conjunction with, or shortly after a meal.

If you use more Fasigyn than you should 

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Fasigyn

Do not take a double dose to make up for a forgotten tablet.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Fasigyn and contact a doctor immediately if you get any of the following symptoms ( angioedema ) (frequency not known ):

  • swelling of the face, tongue, or throat
  • difficulty swallowing
  • hives and difficulty breathing

The following side effects have been reported during treatment with Fasigyn:

Common ( may affect up to 1 in 10 people):

Decreased appetite, dizziness, headache, dizziness, vomiting, diarrhea, nausea, stomach cramps. Taste changes such as metallic taste and bitter taste can be experienced during the treatment but are usually transient. Allergic skin reactions, itching.

Rare ( may affect up to 1 in 1,000 people):

Transient decrease in white blood cells in the blood. Allergic reactions (eg hives). Neurological changes such as muscle weakness in the hands and feet. Inflammation of the oral mucosa. Rash. Dark staining of the urine. Joint pain. Fever. Jaundice, hepatic impairment.

Has been reported (occurs in an unknown number of users): 

Drug hypersensitivity, sudden hypersensitivity reaction with fever, rash, and swelling due to fluid accumulation in the tissues (anaphylactic shock ), severe flushing, shortness of breath, palpitations, pulsating headache, nausea, and vomiting associated with alcohol intake (disulfiram). Seizures, inability to coordinate movements ( ataxia ), sensory disturbances, redness, discoloration of the tongue, tongue inflammation, angioedema, hives, fatigue.

5. How to store Fasigyn

Do not store above 25 ° C.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via 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 packaging and other information

Content declaration

  • The active substance is tinidazole 500 mg per tablet.
  • Other ingredients are Alginic acid, corn starch, microcrystalline cellulose, hypromellose, magnesium stearate, sodium lauryl sulfate, propylene glycol (E 1520), titanium dioxide (E 171).

What the medicine looks like and the contents of the pack

Appearance:

White, round tablets marked with FAS 500.

Pack sizes:

Blisters about 4, 16 resp. 20 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Pfizer AB

191 90 Sollentuna

Email: eumedinfo@pfizer.com

Muhammad Nadeem

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