Tinidazole polpharma

Package leaflet: Information for the patient

Tinidazolum Polpharma, 500 mg, coated tablets
Tinidazolum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

This is an antiprotozoal and antibacterial medicine.
It is used in the treatment of the following infections:

• Anaerobic bacterial infections, such as:
  • peritonitis, intra-abdominal abscess,
  • gynecological infections (endometritis, myometritis, tubo-ovarian abscess),
  • septicemia,
  • post-surgical wound infections,
  • skin and soft tissue infections,
  • respiratory tract infections (pneumonia, lung abscess, empyema).
• Non-specific vaginitis.
• Acute necrotizing ulcerative gingivitis.
• Urogenital trichomoniasis, in both women and men.
• Giardiasis (lambliasis).
• Intestinal amoebiasis.
• Hepatic amoebic abscess.
• Helicobacter pylori infection associated with duodenal and gastric ulcer disease, in combination with other medicines.

It is also used prophylactically:
For the prevention of postoperative infections caused by anaerobic bacteria, particularly following surgery on the colon, stomach and intestines, and gynecological procedures.

2. Important information before using Tinidazolum Polpharma

When not to use Tinidazolum Polpharma:

• if the patient is allergic to tinidazole, derivatives of 5-nitroimidazole, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a neurological disease;
• if the patient currently has or has previously had any blood abnormalities;
• during the first three months of pregnancy;
• during breastfeeding.

Warnings and precautions
Before starting treatment with Tinidazolum Polpharma, discuss this with your doctor or
pharmacist.
During treatment and for at least 3 days after completion of treatment with tinidazole, alcoholic beverages must not be consumed, as this may cause a disulfiram-like reaction (symptoms include: abdominal pain, vomiting, rapid heartbeat, sensation of warmth).
If neurological disturbances occur during treatment with tinidazole, such as: dizziness, ataxia (lack of coordination), peripheral neuropathy (e.g. reduced sensation and muscle strength, muscle atrophy), administration of Tinidazolum Polpharma must be discontinued and the patient should contact a doctor immediately.

Tinidazolum Polpharma and other medicines
Inform your doctor or pharmacist about all medicines currently taken or taken recently, as well as any medicines the patient intends to use.
If the patient is taking anticoagulant medicines (medicines that inhibit blood clotting, used in thromboembolic disorders), this should be reported to the doctor before starting treatment with Tinidazolum Polpharma. The doctor may recommend monitoring blood coagulation tests.

Tinidazolum Polpharma and alcohol
During treatment and for at least 3 days after stopping tinidazole, alcoholic beverages must not be consumed (see: "Warnings and precautions").

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

Pregnancy
This medicine should not be used during the first three months of pregnancy.
From the 4th to the 9th month of pregnancy, the medicine may be used only if, in the opinion of the doctor, it is absolutely necessary.

Breastfeeding
Breastfeeding should not be performed during treatment and for at least 3 days after discontinuation of therapy.

Driving and operating machinery
There is no specific information regarding contraindications to driving vehicles or operating machinery while using tinidazole. However, in some patients, adverse effects such as dizziness, lack of motor coordination, convulsions, or sensory disturbances in the limbs have been observed, which may impair psycho-physical performance. If such adverse effects occur, the patient should not drive or operate machinery and should consult a doctor.

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

3. How to use Tinidazolum Polpharma

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.

Infections caused by anaerobic bacteria

Adults:
On the first day, 4 tablets of 500 mg (2 g of tinidazole) as a single dose, followed by 2 tablets of 500 mg (1 g of tinidazole) per day as a single dose or divided into 2 doses.

Treatment usually lasts from 5 to 6 days, but in some patients, longer treatment may be necessary. If treatment longer than 7 days is indicated, the physician will recommend regular monitoring, including blood tests.

Children under 12 years of age:
Dosage has not been established.

Non-specific vaginitis

Adults:
4 tablets of 500 mg (2 g of tinidazole) as a single dose; higher treatment efficacy has been observed when administering 4 tablets of 500 mg (2 g of tinidazole) per day as 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) as a single dose.

Trichomoniasis

If trichomonas vaginalis infection is confirmed, simultaneous treatment of sexual partners is recommended.

Adults:
4 tablets of 500 mg (2 g of tinidazole) as a single dose.

Children:
50 to 75 mg of tinidazole per kg of body weight as a single dose.

The dose may be repeated if necessary.

Giardiasis

Adults:
4 tablets of 500 mg (2 g of tinidazole) as a single dose.

Children:
50 to 75 mg of tinidazole per kg of body weight as a single dose.

The dose may be repeated if necessary.

Intestinal amoebiasis

Adults:
4 tablets of 500 mg (2 g of tinidazole) per day as a single dose for 2 or 3 consecutive days. If necessary, the physician may extend treatment up to 6 days.

Children:
50 to 60 mg of tinidazole per kg of body weight per day as a single dose for 3 consecutive days.

Amoebic liver abscess

Adults:
Depending on the severity of infection, total treatment course ranges from 4.5 to 12 g of tinidazole; in some patients, drainage of the abscess may be indicated regardless of tinidazole therapy.

Treatment should begin with 3 to 4 tablets (1.5 to 2 g of tinidazole) per day administered as a single dose for 3 consecutive days. If necessary, the physician may extend treatment up to 6 days.

Children:
50 to 60 mg of tinidazole per kg of body weight per day as a single dose for 5 consecutive days.

Helicobacter pylori infections in duodenal and gastric ulcer disease

Adults:
1 tablet (500 mg of tinidazole) twice daily for 7 days, in combination with another antibacterial agent and omeprazole (a medicine that reduces gastric acidity).

The following regimen is recommended:
500 mg of tinidazole twice daily, 250 mg of clarithromycin twice daily, and 20 mg of omeprazole twice daily for 7 days.

Prevention of postoperative infections

Adults:
4 tablets of 500 mg (2 g of tinidazole) as a single dose approximately 12 hours before surgery.

Children under 12 years of age:
Dosage has not been established.

Elderly patients:
No special dosage recommendations.

Method of administration

The medicine should be taken orally, during or after a meal.

Taking more Tinidazolum Polpharma than recommended

If more than the recommended dose is taken, inform the physician immediately.

Missing a dose of Tinidazolum Polpharma

If a dose is missed, 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 regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions are rare, mild or moderate in intensity, and usually resolve spontaneously.
Below are the adverse reactions that may occur during the use of Tinidazolum Polpharma.
Blood and lymphatic system disorders
Transient decrease in the number of white blood cells in blood.
Nervous system disorders
Dizziness, headache, movement incoordination (ataxia), reduced touch sensation, peripheral neuropathy (e.g. decreased sensation and muscle strength, muscle atrophy), seizures, sensory disturbances, sudden skin redness. If such symptoms occur, discontinue use of the medicine and contact your doctor immediately.
Gastrointestinal disorders
Nausea, vomiting, loss of appetite, diarrhoea, 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, pruritus, or angioedema (swelling of the face, tongue and airway, which may impair breathing). If such symptoms occur, seek immediate medical attention.
Renal and urinary disorders
Dark discoloration of urine, fungal infection of the urogenital tract.
General disorders and administration site conditions
Fever, feeling of fatigue.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows the collection of additional information on the safety of the medicine.

5. How to store Tinidazolum Polpharma

Keep this medicine out of sight and reach of children.
Do not store above 25°C. Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
The marking on the packaging following "EXP" indicates the expiry date, and following "Lot/LOT" indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Tinidazolum Polpharma contains

• The active substance is tinidazole. Each tablet contains 500 mg of tinidazole.
• The other ingredients are: tablet core: microcrystalline cellulose, alginic acid, maize 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
Coated tablets, white with a creamish hue, round and biconvex.
The pack contains 4 or 16 tablets in blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
POLPHARMA SA Pharmaceutical Works
Pelplińska Street 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Manufacturer
POLPHARMA SA Pharmaceutical Works
Pelplińska Street 19, 83-200 Starogard Gdański

POLPHARMA SA Pharmaceutical Works
Medana Plant in Sieradz
Władysława Łokietka Street 10, 98-200 Sieradz