Document: Tiacur Solution for injection ENG PL change

• Tiacur Solution for injection PL
• Tiacur Solution for injection ENG PL

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Package leaflet: Information for the user

Tiacur 25 mg/ml, solution for injection

Tiacur 50 mg/ml, solution for injection

thiamine hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor, pharmacist or nurse.

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

What is in this leaflet

1. What Tiacur is and what it is used for

2. What you need to know before you use Tiacur

3. How to use Tiacur

4. Possible side effects

6. Contents of the pack and other information

The active substance in Tiacur is Vitamin B₁ in the form of thiamine hydrochloride. Tiacur is used to treat conditions where there is a deficiency of Vitamin B₁e.g.malabsorption, anorexia or alcohol addiction.

Do not use Tiacur:

- if you are allergic to thiamine hydrochloride or any of the other ingredients of this medicine (listed in section 6.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Tiacur. Especially if you have ever had a mild allergic reaction to any previous injections of vitamin B1 (thiamine). This could mean that you may have become hypersensitive, and could have a more severe allergic reaction if given Tiacur.

Other medicines and Tiacur

Tell your doctor if you are using, have recently used or might use any other medicines.

Remember to tell your doctor if you use medicines containing furosemide (diuretics), since furosemid may lower your thiamine levels.

Pregnancy,breast-feeding and fertility

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

Driving and using machines

Tiacur is not expected to affect your ability to drive or operate machinery.

The exact dose you will be given will be decided by your doctor who will monitor your condition

and determine what treatment you need. If you feel that you have been given an inappropriate

dose or if you would like more information about Tiacur, speak to your doctor.

If you use more Tiacur than you should

This product will be given to you under medical supervision. It is therefore unlikely that you will be

given too much. However, if you feel unwell, you should tell your doctor immediately.

If you stop using Tiacur

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

4. Possible side effects

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

Not known: frequency cannot be estimated from the available data: local irritation at injection site, skin rash, itching, heavy blood pressure decrease, breathlessness.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse.This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below) .By reporting side effects you can help provide more information on the safety of this medicine.

[To be completed nationally]

5. How to store Tiacur

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

Store in original package in order to protect from light.

Do not store above 25 °C. Do not freeze.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Tiacur contains

• The active substance is thiamine hydrochloride

• The other ingredients are water for injections, sodium chloride, chlorobutanol hemihydrate, hydrochlorid acid (for pH adjustment), sodium hydroxide (for pH adjustment).

What Tiacur looks like and contents of the pack

Colourless glass ampoules (type I): 5 x 2 ml, 10 x 2 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Abcur AB

Box 1452

251 14 Helsingborg

This leaflet was last revised in: 2015-01-21