Liquid Paraffin 500ml hazelnut Restrical

NOTICE

ANSM - Last updated: 17/07/2017

Name of the medicinal product

RESTRICAL NOISETTE, oral solution

Liquid Paraffin

framed

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

You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.

· Keep this leaflet. You might need to read it again.

· Ask your pharmacist for advice or information.

· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

· You should talk to your doctor if you do not feel better or feel less well.

What is in this leaflet?

1. What is RESTRICAL NOISETTE, oral solution and in which cases it is used?

2. What should I tell you before taking RESTRICAL NOISETTE, oral solution?

3. How to take RESTRICAL NOISETTE, oral solution?

4. What are the possible side effects?

5. How to store RESTRICAL NOISETTE, oral solution ?

6. Package contents and other information.

1. WHAT IS RESTRICTION NOISETTE, oral solution AND WHAT IT IS USED FOR?

This medication is a laxative used orally.

It is recommended in occasional constipations.

It usually works 6 to 8 hours after taking.

2. BEFORE YOU TAKE RESTRICTION NOISETTE, oral solution?

Do not take RESTRICAL NOISETTE, oral solution :

· if you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6.

· if you suffer from abdominal pain that you do not know the cause,

· if you have swallowing difficulties (swallow properly) due to the risk of bronchial inhalation and lipoid pneumonitis.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

Warnings and Precautions

Talk to your doctor or pharmacist before taking RESTRICAL NOISETTE, oral solution.

Special warnings

NO PROLONGED USE WITHOUT MEDICAL ADVICE.

· The administration of paraffin oil in young children, patients bedridden or having difficulty swallowing should be cautious as it may cause bronchial passages and respiratory disorders.

In general, do not administer this medication before bed.

Occasional constipation:

It may be related to a recent change in lifestyle (travel). The drug may be an aid in short treatment. Any recent constipation unexplained by the change in lifestyle, constipation accompanied by pain, fever, swelling of the abdomen must make seek the opinion of the doctor.

Chronic constipation (long-term constipation):

It can be linked to two causes:

· a disease of the intestine that requires treatment by the physician,

· or an imbalance in intestinal function due to dietary habits and lifestyle.

Treatment includes:

· an increase in dietary intakes of vegetable products (green vegetables, raw vegetables, wholemeal bread, fruit ...)

· an increase in the consumption of water and fruit juices

· an increase in physical activities (sports, walking ...)

· rehabilitation of defecation reflex

· sometimes, adding sound to the diet.

It is helpful to seek advice from your doctor or pharmacist.

children

In children the treatment of constipation is based on lifestyle and dietary measures: in particular the use of the right amount of water with infant milk powders, a diet rich in vegetable products, addition of Juice.

Regular intake of laxatives in young age may interfere with the normal functioning of the defecation reflex).

Precautions for use

· This oil should not be heated.

· Prolonged use of paraffin oil is likely to decrease the absorption of certain vitamins.

IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.

Other medicines and RESTRICAL NOISETTE , oral solution

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

RESTRICAL NOISETTE, oral solution with food and beverages

Not applicable.

Pregnancy and breast feeding

This medication under normal conditions of use may be used occasionally during pregnancy and lactation.

If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor for advice or pharmacist before taking this medication.

Driving and using machines

Not applicable.

RESTRICAL NOISETTE, oral solution contains

Not applicable.

3. HOW TO TAKE RESTRICAL HAZELNUT, oral solution?

Dosage

Adult: the usual dosage is 1 to 3 tablespoons per day.

Children over 6 years: 1 to 3 teaspoons per day.

Children under 6 years of age: according to medical advice.

The dose may be taken one or more times preferably in the morning on an empty stomach, 2 hours before or after meals. If taken at night, avoid sleeping within 2 hours (see Special Warnings) and take into account that the laxative effect may occur during the night.

IN ALL CASES CONFORM TO THE ORDER OF YOUR DOCTOR STRICTLY.

If you have used more RESTRICAL NOISETTE, oral solution than you should:

A high-dose use of liquid paraffin is liable to:

· steatorrhea (fatty diarrhea),

· anal seeping,

· perianal irritation.

If you have taken more RESTRICAL HAZELNUT, a non-prescription oral solution, stop treatment and contact your doctor or pharmacist.

If you forget to take RESTRICAL NOISETTE, oral solution

Not applicable.

If you stop taking RESTRICAL NOISETTE, oral solution

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

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

· in exceptional conditions or due to misuse, possibilities of respiratory disorders,

· in high doses, risk of oily flow or irritation in the anus.

If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.

Declaration of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE RESTRICAL NOISETTE, oral solution?

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

Do not use this medicine after the expiry date which is stated on the outer packaging.

This medication should be stored in a dark place.

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What RESTRICAL NOISETTE contains, oral solution

· The active substance is:

Liquid paraffin ................................................ .................................................. 85.500 g

For 100 ml oral solution

· The other components are:

Glycerides of peanut oil (Olicine), beta carotene, hazelnut aroma⃰.

⃰ Composition of the hazelnut aroma : extracts of malt, fenugreek and vanilla-caramel sugar, alcohol 20 °.

What is RESTRICAL NOISETTE, oral solution and contents of the pack

This medication is in the form of a drinkable solution; 500 ml bottle.

Marketing Authorization Holder

LABORATOIRES THERANOL DEGLAUDE

72, RUE DU FAUBOURG SAINT HONORE

75008 PARIS

LA FRANCE

Marketing Authorization Operator

DB PHARMA

1 BIS, RUE DU COMMANDANT RIVIERE

94210 LA VARENNE SAINT HILAIRE

LA FRANCE

Maker

FARMACLAIR

440, AVENUE DU GENERAL DE GAULLE

14200 HEROUVILLE SAINT CLAIR

LA FRANCE

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is:

December 2015

Other

Detailed information on this medicine is available on the ANSM website (France).

VIDAL OF THE FAMILY

RESTRICAL