SPASMABOSTON 60

POSOLOGY, METHOD OF ADMINISTRATION

Posology

Children 12 years and older, adults and the elderly

1 or 2 capsules for one to three times daily.

Children below the age of 12 years

SPASMABOSTON 60 is not recommended.

Method of administration

Oral.

CONTRAINDICATIONS

Hypertensitivity to the active substance or to any of the excipients.

Paralytic ileus, intestinal obstruction.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

If you have had these symptoms, do not use this medicine and see your doctor as soon as possible:

Aged 40 years or over.

Have passed blood from the bowel.

Feeling tired, looking pale, fever or vomiting.

Lost your appetite or lost weight.

Severe constipation.

Have recently travelled abroad.

You are or may be pregnant.

Abnormal vaginal bleeding or discharge.

Difficulty or pain passing urine.

Consult your doctor if you have developed new symptoms, or if your symptoms worsen or if they do not improve after 2 weeks treatment.

Be careful with excipients

This product contains FD & C yellow 5: Can cause allergic reaction.

PREGNANCY AND LACTATION

Pregnancy
- Although no teratogenic effects have been reported, use this medicine during pregnancy is not recommend as evidence of safety is limited.

Lactation

This medicine is not recommended using during laction.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

 This medicine may cause dizziness. Do not drive or use machinery if affected.

INTERACTION WITH OTHER MEDICINAL PRODUCTS

There are currently no reported drug interactions.

UNDERSIRABLE EFFECTS

Frequency is classified as follows: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1.000 to < 1/100), Rare (≥ 1/10.000 to < 1/1.000), Very rare (<1/10.000), Not known (cannot be estimated from the available data)

Report of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report ant suspected adverse reactions via The National Centre of Drug Information and Adverse Drug Reactions Monitoring (National DI & ADR Centre).

Treatment ADR

ADRs are usually mild and do not require treatment. If you experience itching or rash, you should stop taking the drug and monitor for anaphylactic reactions, although this is very rare.

SHELF-LIFE

36 months from the manufacturing date (do not use after the expiry date).

STORAGE

Store in a dry place, below 30ºC, protect from light.

Al/PVDC blister. Box of 03 blisters x 10 hard capsules.