GRANUPAS 4 g gastro-resistant granules

Introduction

Package Leaflet: Information for the Patient

GRANUPAS 4 g Gastro-Resistant Granules

Para-aminosalicylic acid

Read all of this leaflet carefully before you start taking 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 or pharmacist.

• 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.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is GRANUPAS and what is it used for

1. What you need to know before you take GRANUPAS
2. How to take GRANUPAS

1. Possible side effects
2. Storage of GRANUPAS
3. Contents of the pack and other information

1. What is GRANUPAS and what is it used for

GRANUPAS contains para-aminosalicylic acid which is used in adults and in children from 28 days of age or older to treat resistant tuberculosis, in combination with other medicines, in cases of resistance or intolerance to other treatments.

2. What you need to know before you take GRANUPAS

Do not take GRANUPAS

• if you are allergic to para-aminosalicylic acid or any of the other ingredients of this medicine (listed in section 6).

• if you have severe kidney disease.

If you are not sure, consult your doctor or pharmacist before taking GRANUPAS.

Warnings and precautions

Consult your doctor or pharmacist or nurse before starting treatment with GRANUPAS

• if you have liver problems or mild or moderate kidney disease

• if you have a stomach ulcer

• if you are infected with HIV

Children

GRANUPAS is not recommended for use in newborn babies (less than 28 days old).

Other medicines and GRANUPAS

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

It is especially important that you tell your doctor if you are taking any of the following medicines:

• Anti-tuberculosis medicines or ethionamide (other treatments for tuberculosis)

• Vitamin B12

• Digoxin (for heart disease)

• Diphenhydramine (for allergic reactions)

Pregnancy and breast-feeding

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.

GRANUPAS should not be taken during pregnancy and should only be used if your doctor considers it essential. Do not breast-feed while taking GRANUPAS, as small amounts of this medicine may pass into breast milk.

Driving and using machines

GRANUPAS is unlikely to affect your ability to drive or use machines. If this happens, tell your doctor or pharmacist.

3. How to take GRANUPAS

Follow exactly the administration instructions of this medicine given by your doctor.

In case of doubt, ask your doctor or pharmacist.

Adults

The recommended dose for adults is 1 sachet, 3 times a day, with a schedule of 1 sachet every 8 hours. Your doctor may need to start treatment with a lower dose to avoid possible side effects.

Do not take more than 3 sachets per day. The treatment is usually given for two years (24 months).

• Empty the contents of the sachet into a glass of tomato or orange juice.

• Drink it immediately.

• If some granules remain in the glass, add a little more juice and drink it immediately.

Use in infants, children and adolescents

The doctor will calculate the dose for infants, children and adolescents based on the patient's body weight. The recommended total daily dose is 150 mg per kg of body weight. This daily amount is divided into two doses distributed throughout the day.

• Use the measuring spoon provided with the medicine to measure the dose.

• To measure the dose:
1. The lines on the measuring spoon indicate the amount (in milligrams of para-aminosalicylic acid). Take the correct amount that your doctor has prescribed.
1. Put the granules directly into the measuring spoon.
   1. Gently tap the measuring spoon on a table to level the granules horizontally and fill it more if necessary.
• Sprinkle the granules over apple puree or yoghurt.
• Have your child eat it immediately.

Use of this medicine

• Do not crush or chew the granules. Swallow the granules whole. It is important that you do not dissolve, crush or chew the granules, as they may not be absorbed correctly and may cause stomach pain or bleeding.
• Do not use the sachet if it is swollen or the granules have lost their original light brown color.
• You may see granules in the stool; this is normal.

If you take more GRANUPAS than you should

Consult your doctor or pharmacist.

If you forget to take a dose of GRANUPAS

Do not take a double dose to make up for forgotten doses. Wait until the next dose is due and take the usual dose.

If you have any other questions on how to use 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.

During the first 3 months of your treatment with GRANUPAS, you should pay attention to any signs of an allergic reaction (such as rash, red spots on the skin that itch, itching, hives, watery eyes, itchy eyes or nasal congestion) or hepatitis (such as fever, fatigue, dark urine, very light stools, abdominal pain, yellow skin and eyes). If you experience any of these symptoms, you should consult your doctor immediately.

Common side effects (occurring in more than 1 patient in 100):

• dizziness,
• stomach pain (abdominal pain),
• vomiting,
• nausea,
• hiccups,
• diarrhea,
• soft stools,
• redness of the skin or rash,
• alteration of gait or balance.

Uncommon side effects (occurring in more than 1 patient in 1,000):

• loss of appetite (anorexia)

Rare side effects (occurring in more than 1 patient in 10,000):

• thyroid problems*,
• decreased ability to absorb nutrients from food,
• ulcer, intestinal bleeding,
• yellowing of the skin or eyes (jaundice),
• metallic taste,
• itchy rash.
• In people also infected with HIV, thyroid problems, in particular insufficient thyroid activity or low levels of thyroid hormones, are a very common side effect that may affect more than 1 in 10 people. Periodic monitoring of thyroid function is recommended for all people with HIV.

Very rare side effects (occurring in less than 1 patient in 10,000):

• reduction in the number of blood platelets,
• red spots on the skin,
• reduction in the number of white blood cells,
• reduction in the number of red blood cells,
• reduction in the ability of red blood cells to release oxygen,
• low blood sugar levels,
• tendon pain, headache,
• visual disturbances, nerve damage to hands and feet,
• dizziness,
• crystals in the urine.
• prolonged bleeding time,
• liver cell destruction,
• high enzyme levels,
• weight loss,

Side effects of unknown frequency (cannot be estimated from the available data)

• hepatitis

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of GRANUPAS

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 sachet after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C. Once opened, the sachets can be stored below 25°C for up to 24 hours.

Do not use this medicine if you notice that the sachets are swollen or the granules are dark brown or purple in color

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of GRANUPAS

The active substance is para-aminosalicylic acid.

Each sachet of gastro-resistant granules contains 4 g of para-aminosalicylic acid.

The other ingredients are colloidal silicon dioxide, dibutyl sebacate, methacrylic acid copolymer (1:1) dispersion 30%, hypromellose, microcrystalline cellulose, talc.

Appearance and packaging of the product

This medicine is presented as a light brown gastro-resistant granule in sachets.

Each carton contains 30 sachets. A measuring spoon is provided.

Marketing authorisation holder

Eurocept International BV

Trapgans 5

1244 RL Ankeveen

The Netherlands

Manufacturer

Lucane Pharma

172 rue de Charonne

75011 Paris

France

Eurocept International BV

Trapgans 5

1244 RL Ankeveen

The Netherlands

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Belgium/Belgique/Belgien	Lithuania
Lucane Pharma	FrostPharma AB
Tel: + 33 153 868 750	Tel: +46 775 86 80 02
[email protected]		[email protected]

Bulgaria		Luxembourg/Luxemburg
Lucane Pharma		Lucane Pharma
Tel: + 33 153 868 750		Tel: + 33 153 868 750
[email protected]		[email protected]

Czech Republic		Hungary
Lucane Pharma		Lucane Pharma
Tel: + 33 153 868 750		Tel: + 33 153 868 750
[email protected]		[email protected]

Denmark		Malta
FrostPharma AB		Lucane Pharma
Tel: +45 808 20 101		Tel: + 33 153 868 750
[email protected]		[email protected]

Germany	Netherlands
Lucane Pharma	Eurocept International BV
Tel: + 33 153 868 750	Tel: +31 35 528 39 57
[email protected]	[email protected]

Estonia		Norway
FrostPharma AB		FrostPharma AB
Tel: +46 775 86 80 02		Tel: +47 815 03 175
[email protected]		[email protected]

Greece		Austria
Lucane Pharma		Lucane Pharma
Tel: + 33 153 868 750		Tel: + 33 153 868 750
[email protected]		[email protected]

Spain		Poland
Lucane Pharma		Lucane Pharma
Tel: + 33 153 868 750		Tel: + 33 153 868 750
[email protected]		[email protected]

France		Portugal
Lucane Pharma		Overpharma
Tel: + 33 153 868 750		Tel: +351 214 307 760
[email protected]		[email protected]

Croatia		Romania
Lucane Pharma		Lucane Pharma
Tel: + 33 153 868 750		Tel: + 33 153 868 750
[email protected]		[email protected]

Ireland		Slovenia
Lucane Pharma		Lucane Pharma
Tel: + 33 153 868 750		Tel: + 33 153 868 750
[email protected]		[email protected]

Iceland		Slovakia
FrostPharma AB		Lucane Pharma
Tel: +46 775 86 80 02		Tel: + 33 153 868 750
[email protected]		[email protected]

Italy		Finland
Lucane Pharma		FrostPharma AB
Tel: + 33 153 868 750		Tel: +35 875 32 51 209
[email protected]		[email protected]

Cyprus		Sweden
Lucane Pharma		FrostPharma AB
Tel: + 33 153 868 750		Tel: +46 775 86 80 02
[email protected]		[email protected]

Latvia		United Kingdom
FrostPharma AB		Lucane Pharma
Tel: +46 775 86 80 02		Tel: + 33 153 868 750
[email protected]		[email protected]

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

There are also links to other websites on rare diseases and orphan medicines.