Trimonase

Package leaflet: Information for the patient

TRIMONASE 500 mg tablets

Tinidazole
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What TRIMONASE is and what it is used for
2. What you need to know before taking TRIMONASE
3. How to take TRIMONASE
4. Possible side effects
5. How to store TRIMONASE
6. Contents of the pack and other information

1. What TRIMONASE is and what it is used for

TRIMONASE contains tinidazole, an active substance that inhibits the growth of an organism called
Trichomonas vaginalis (trichomonacide); it also acts against other organisms such as Lamblia
intestinalis and Entamoeba histolytica.
TRIMONASE is used in adults for the treatment of:

• urinary and genital tract infections caused by Trichomonas vaginalis;
• infections caused by Lamblia intestinalis and Entamoeba histolytica.

Contact your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking TRIMONASE

Do not take TRIMONASE

• if you are allergic to tinidazole or to any of the other ingredients of this medicine (listed in section 6);
• if you have had or currently have blood disorders;
• if you have had nervous system disorders;
• if you are in the first 3 months of pregnancy or if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking TRIMONASE.
TRIMONASE and alcohol
Children and adolescents
This medicine is not recommended for children and adolescents (0–18 years) as safety and efficacy have not been established.
Other medicines and TRIMONASE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
TRIMONASE with alcohol
On the day you start treatment with TRIMONASE and during the following days, avoid consuming alcoholic beverages, as you may experience abdominal cramps, vomiting, and facial flushing.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take TRIMONASE during the first 3 months of pregnancy.
Breastfeeding
Driving and using machines
TRIMONASE contains lactose

3. How to take TRIMONASE

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.

• Urinary and genital infections caused by Trichomonas vaginalis
  Dosage 4 tablets once daily

Treatment duration
Take TRIMONASE for 1 day.
Your doctor may instruct you to take this medicine again after 8 days, depending on whether the infection
has recurred.

• Infections caused by Lamblia intestinalis and Entamoeba histolica
  Dosage 1-3 tablets daily

Treatment duration
Take TRIMONASE for 5 consecutive days.
How to take
Swallow the tablets with some liquid.

If you take more TRIMONASE than you should
If you take more TRIMONASE than prescribed, contact your doctor or go to the nearest hospital immediately.

If you forget to take TRIMONASE
Do not take a double dose to make up for the missed tablet.

If you stop taking TRIMONASE
If you have any doubts about using TRIMONASE, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If you experience any of the following adverse reactions while being treated with TRIMONASE, STOP
treatment immediately and consult your doctor or go to the nearest hospital:

• allergic reaction
• disorders of the central nervous system.

The following adverse reactions have been reported during treatment with TRIMONASE:
Blood-related effects

• decrease in white blood cells (leucopenia)

Immune system disorders

• Hypersensitivity

Metabolism and nutrition disorders

• Loss of appetite

Nervous system disorders

• Headache, seizures, worsening or impaired function of peripheral nerves (peripheral neuropathy, paresthesia, reduced sensation (hypoesthesia), sensory disturbances, ataxia), dizziness, dysgeusia

Ear and labyrinth disorders

• Vertigo

Vascular disorders

• Hot flushes

Gastrointestinal disorders

• Diarrhea, nausea, abdominal pain, glossitis, stomatitis, change in tongue colour

Skin and subcutaneous tissue disorders

• Allergic dermatitis, pruritus, angioedema, urticaria

Renal and urinary disorders

• Coloured urine (chromaturia)

Systemic disorders and administration site conditions

• Fever, fatigue

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions may also be reported directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store TRIMONASE

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month. The expiry date applies to the product stored in its original, unopened packaging and properly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TRIMONASE 500 mg tablets contains

• The active substance is tinidazole. One tablet contains 500 mg of tinidazole.
• The other components are: lactose monohydrate, lactose anhydrous (see section “TRIMONASE contains lactose”), microcrystalline cellulose, povidone, sodium croscarmellose, magnesium stearate.

Description of the appearance of TRIMONASE and package contents
It is presented as white tablets for oral use. It is available in packs of 8 tablets contained in a blister.
Marketing Authorization Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome
Manufacturer
Mipharm S.p.A.
Via B. Quaranta, 12
20141 Milan (Italy)