Crampex TabletsCholecalciferol 0.02 mgCalcium Gluconate 200 mgNicotinic Acid 20 mg

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Cholecalciferol; Calcium gluconate; Nicotinic acid

Disponible des:

Clonmel Healthcare Ltd

Codi ATC:

A12AX

Designació comuna internacional (DCI):

Cholecalciferol; Calcium gluconate; Nicotinic acid

Dosis:

0.02 mg/200 mg/20 milligram(s)

formulario farmacéutico:

Tablet

Área terapéutica:

Calcium, combinations with vitamin D and/or other drugs

Estat d'Autorització:

Not marketed

Data d'autorització:

1993-04-23

Informació per a l'usuari

CF/REG/96/2
PRODUCT NAME
Crampex Tablets
PACKAGING TYPE
Leaflet
CATEGORY/PL NO.
PM/20/376
TEXT REVISION NO.
0
PAGE #
1 of 4
COMPONENT
PACK SIZE
IG CODE:
CURRENT V#: NEW V#:
REVISED BY:
DATE:
AUTHORISED BY:
DATE:
Leaflet
24’s
9279744
1710
1903
CRN
DESCRIPTION
15905
Transfer license to Clonmel for Brexit
PACKAGE LEAFLET: INFORMATION FOR THE USER
CRAMPEX TABLETS
nicotinic acid 20mg
calcium gluconate 200mg
cholecalciferol 0.02mg
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take Crampex Tablets carefully to
get the best results from it.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need any more information or advice.

You must contact your doctor if your symptoms worsen or do not
improve.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Crampex Tablets are and what they are used for
2.
Before you take Crampex Tablets
3.
How to take Crampex Tablets
4.
Possible side effects
5.
How to store Crampex Tablets
6.
Further information
1. WHAT CRAMPEX TABLETS ARE AND WHAT THEY ARE USED FOR
Crampex Tablets contain calcium gluconate and cholecalciferol to
increase calcium levels in the blood as
low levels of calcium can contribute to muscle cramps. They also
contain nicotinic acid to improve
circulation.
The tablets are for night time muscle cramp.
2. BEFORE YOU TAKE CRAMPEX TABLETS
DO NOT TAKE THE MEDICINE IF YOU HAVE….

An ALLERGY to any of the ingredients listed in section 6.

An EXCESSIVE amount of CALCIUM IN YOUR BLOOD. TAKE SPECIAL CARE WITH CRAMPEX TABLETS IF YOU HAVE….

Poor kidney function or have a tendency to form kidney stones.
Treatment with Crampex should be
kept as short as possible if this applies.
CF/REG/96
PRODUCT
NAME
Crampex Tablets
CATEGORY/PL
NO.
PM/20/376
TEXT REVISION
NO.
0
PAGE # 2 of 4

High blood pressure.
�

Fitxa tècnica

Health Products Regulatory Authority
31 May 2019
CRN008YWP
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Crampex TabletsCholecalciferol 0.02 mgCalcium Gluconate 200
mgNicotinic Acid 20 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Colecalciferol
20
micrograms
Calcium Gluconate
200
mg
Nicotinic Acid
20
mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
Flat, circular bevel-edged white tablets with the word ‘Crampex’
engraved on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For treatment of night muscle cramp.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral.
Adults only (including elderly):
1 or 2 tablets before retiring.
Children:
Not recommended.
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
Do not use in patients with hypercalcaemia.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Duration of treatment should be minimised in patients with impaired
renal function or a tendency to form kidney stones.
Use with caution in patients with hypertension, a history of peptic
ulcer disease, diabetes mellitus, gout or impaired liver
function.
Not recommended for use in children.
Prolonged use is not recommended.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
Use with caution in patients taking digitalis.
Health Products Regulatory Authority
31 May 2019
CRN008YWP
Page 2 of 3
4.6 FERTILITY, PREGNANCY AND LACTATION
This product should not be used during pregnancy or in women breast
feeding infants.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None stated.
4.8 UNDESIRABLE EFFECTS
Side effects may include erythema, itching or urticaria. Occasionally,
hot flushes in sensitive individuals.
Nicotinic acid may cause dizziness, headache, nausea, vomiting and
rarely impaired liver function.
Calcium supplements may cause mild gastrointestinal disturbances.
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting suspected adverse reactions after authorisation of the
medicinal product is impo