Tinidazolum Polpharma

Package Leaflet: Information for the Patient

Tinidazolum Polpharma, 500 mg, Film-Coated Tablets

Tinidazolum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Tinidazolum Polpharma and what is it used for
• 2. Important information before taking Tinidazolum Polpharma
• 3. How to take Tinidazolum Polpharma
• 4. Possible side effects
• 5. How to store Tinidazolum Polpharma
• 6. Contents of the pack and other information

1. What is Tinidazolum Polpharma and what is it used for

This is an anti-protozoal and antibacterial medicine.
It is used to treat the following infections

• Infections with anaerobic bacteria, such as:
• peritonitis, intra-abdominal abscess,
• gynecological infections (endometritis, myometritis, tubo-ovarian abscess),
• septicemia,
• surgical wound infections,
• skin and soft tissue infections,
• respiratory tract infections (pneumonia, lung abscess).
• Non-specific vaginitis.
• Acute necrotizing ulcerative gingivitis.
• Trichomoniasis of the urogenital tract, in both women and men.
• Giardiasis (lambliasis).
• Intestinal amoebiasis.
• Amebic liver abscess.
• Helicobacter pyloriinfection, which occurs in duodenal and gastric ulcer disease, in combination with other medicines.

It is also used as a preventive measure
In the prevention of postoperative infections caused by anaerobic bacteria, especially after
operations on the colon, stomach, and intestines, as well as gynecological operations.

2. Important information before taking Tinidazolum Polpharma

When not to take Tinidazolum Polpharma:

• during the first three months of pregnancy;
• during breastfeeding.

Warnings and precautions

Before taking Tinidazolum Polpharma, discuss it with your doctor or
pharmacist.
During treatment and for at least 3 days after the end of treatment with tinidazole, do notconsume
alcoholic beverages, as a disulfiram-like effect may occur (symptoms include: abdominal pain,
vomiting, rapid heartbeat, feeling of heat).
If neurological disorders occur during treatment with tinidazole, such as: dizziness, ataxia
(lack of coordination), peripheral neuropathy (e.g. weakness of sensation and muscle strength, muscle atrophy), seizures, or sensory disturbances, discontinue taking Tinidazolum Polpharma and contact your doctor immediately.

Tinidazolum Polpharma and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
If you are taking a medicine from the group of anticoagulants (medicines that inhibit blood clotting,
used in thromboembolic diseases), inform your doctor before starting treatment with Tinidazolum Polpharma. Your doctor may recommend blood coagulation tests.

Tinidazolum Polpharma and alcohol

During treatment and for at least 3 days after the end of treatment with tinidazole do notconsume
alcoholic beverages (see: "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Pregnancy
Do not take this medicine during the first three months of pregnancy.
From the 4th to the 9th month of pregnancy, this medicine can only be used if your doctor considers it absolutely necessary.
Breastfeeding
Do not breastfeed while taking this medicine and for at least 3 days after stopping treatment.

Driving and using machines

There is no information on contraindications for driving vehicles and operating machines while taking tinidazole. However, some patients have reported side effects such as:
dizziness, lack of coordination, seizures, or sensory disturbances, which may impair psychophysical fitness. If such side effects occur, do not drive vehicles or operate machines, but consult your doctor.

Tinidazolum Polpharma contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Tinidazolum Polpharma

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Infections caused by anaerobic bacteria
Adults:
on the first day, 4 tablets of 500 mg (2 g of tinidazole) in a single dose, and then 2 tablets of 500 mg
(1 g of tinidazole) per day in a single dose or in 2 divided doses.
Treatment usually lasts from 5 to 6 days, but in some patients, longer treatment may be necessary. If treatment is to be longer than 7 days, your doctor will recommend regular tests, including blood tests.
Children under 12 years of age:
the dosage has not been determined.
Non-specific vaginitis
Adults:
4 tablets of 500 mg (2 g of tinidazole) in a single dose; greater efficacy has been observed after
taking 4 tablets of 500 mg (2 g of tinidazole) per day in a single dose for 2 days (total therapeutic dose: 4 g).
Acute necrotizing ulcerative gingivitis
Adults:
4 tablets of 500 mg (2 g of tinidazole) in a single dose.
Trichomoniasis
If trichomoniasis is confirmed, it is recommended to treat sexual partners at the same time.
Adults:
4 tablets of 500 mg (2 g of tinidazole) in a single dose.
Children:
50 to 75 mg per kg of body weight in a single dose.
The dose can be repeated if necessary.
Giardiasis
Adults:
4 tablets of 500 mg (2 g of tinidazole) in a single dose.
Children:
50 to 75 mg of tinidazole per kg of body weight in a single dose.
The dose can be repeated if necessary.
Intestinal amoebiasis
Adults:
4 tablets of 500 mg (2 g of tinidazole) per day in a single dose for 2 or 3 consecutive days. If necessary, the doctor may extend the treatment to 6 days.
Children:
50 to 60 mg of tinidazole per kg of body weight per day in a single dose for 3 consecutive days.
Amebic liver abscess
Adults:
depending on the severity of the infection, from 4.5 to 12 g of tinidazole for the entire treatment; in some patients, it may be necessary to remove the abscess contents independently of tinidazole treatment.
Treatment should be started with 3 to 4 tablets (1.5 to 2 g of tinidazole) per day, given in a single dose for 3 consecutive days. If necessary, the doctor may extend the treatment to 6 days.
Children:
50 to 60 mg of tinidazole per kg of body weight per day in a single dose for 5 consecutive days.
Helicobacter pylori infections, which occur in duodenal and gastric ulcer disease
Adults:
1 tablet (500 mg of tinidazole) twice a day for 7 days in combination with another antibacterial medicine and omeprazole (a medicine that reduces stomach acid).
The recommended dosing regimen is:
500 mg of tinidazole twice a day, 250 mg of clarithromycin twice a day, and 20 mg of omeprazole twice a day for 7 days.
Prevention of postoperative infections
Adults:
4 tablets of 500 mg (2 g of tinidazole) in a single dose, approximately 12 hours before surgery.
Children under 12 years of age:
the dosage has not been determined.
Elderly patients:
there are no special dosage recommendations.
Method of administration
Take the medicine orally, during or after a meal.

Overdose of Tinidazolum Polpharma

If you have taken more than the recommended dose of the medicine, inform your doctor immediately.

Missed dose of Tinidazolum Polpharma

If you have missed a dose, take it as soon as possible. Do not take a double dose to make up for the missed dose.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are rare, have mild or moderate intensity, and usually disappear on their own.
The following side effects may occur when taking Tinidazolum Polpharma.

Blood and lymphatic system disorders

Temporary decrease in white blood cell count.

Nervous system disorders

Dizziness, headache, lack of coordination (ataxia), decreased sensation, peripheral neuropathy (e.g. weakness of sensation and muscle strength, muscle atrophy), seizures, sensory disturbances, sudden flushing of the skin. If such symptoms occur, discontinue taking the medicine and contact your doctor.

Gastrointestinal disorders

Nausea, vomiting, loss of appetite, diarrhea, abdominal pain, coated tongue (white coating on the tongue), glossitis, stomatitis, metallic taste in the mouth.

Skin and subcutaneous tissue disorders

Hypersensitivity reactions, sometimes severe; may manifest as rash, urticaria, itching, or angioedema (swelling of the face, tongue, and larynx, which can make breathing difficult).
If such symptoms occur, seek medical attention immediately.

Renal and urinary disorders

Dark urine, fungal infections of the urogenital tract.

General disorders and administration site conditions

Fever, feeling of fatigue.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tinidazolum Polpharma

Keep the medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package.
Do not use this medicine after the expiry date stated on the package.
The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Tinidazolum Polpharma contains

• The active substance of the medicine is tinidazole. Each tablet contains 500 mg of tinidazole.
• The other ingredients are: tablet core: microcrystalline cellulose, alginic acid, corn starch, sodium lauryl sulfate, magnesium stearate; coating: hypromellose, talc, titanium dioxide (E171), macrogol 6000, propylene glycol.

What Tinidazolum Polpharma looks like and contents of the pack

White to cream-colored, round, and biconvex film-coated tablets.
The package contains 4 or 16 tablets in blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Polpharma S.A.
Medana Division in Sieradz
Władysława Łokietka 10, 98-200 Sieradz

Date of last revision of the leaflet: