Spasmolina

Leaflet attached to the packaging: patient information

Spasmolina, 60 mg, hard capsules

Alverini citras

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Spasmolina and what is it used for
• 2. Important information before taking Spasmolina
• 3. How to take Spasmolina
• 4. Possible side effects
• 5. How to store Spasmolina
• 6. Contents of the packaging and other information

1. What is Spasmolina and what is it used for

Spasmolina contains the active substance alverine citrate, which acts as an antispasmodic.
The mechanism of action is mainly based on a direct effect on smooth muscles.
The medicine is used:

• for symptomatic treatment of smooth muscle spasm in the gastrointestinal tract, bile ducts, urinary tract, and uterus;
• as an antispasmodic in irritable bowel syndrome, painful diverticulosis of the colon, and painful menstruation. Due to the lack of anticholinergic effect, Spasmolina can be used in patients with glaucoma or prostatic hyperplasia.

2. Important information before taking Spasmolina

When not to take Spasmolina:

Warnings and precautions

Before starting to take Spasmolina, discuss it with your doctor or pharmacist.
Be particularly cautious when taking Spasmolina:

Children

Spasmolina should not be used in children under 12 years of age.

Spasmolina and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
No interactions have been found between Spasmolina and other medicines.

Spasmolina with food and drink

The medicine can be taken independently of meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Pregnancy
Spasmolina should not be used during pregnancy. The medicine can only be used during pregnancy if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding
Spasmolina should not be used during breastfeeding.

Driving and using machines

Spasmolina has no effect or negligible effect on the ability to drive and use machines.

Spasmolina contains sorbitol

Spasmolina contains 35 mg of sorbitol in each capsule.
Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, the patient should consult their doctor before taking the medicine or giving it to their child.

The medicine contains quinoline yellow (E 104) and orange yellow (E 110)

The medicine may cause allergic reactions.

3. How to take Spasmolina

Take this medicine exactly as described in the patient information leaflet or as directed by your doctor.
If you have any doubts, consult your doctor or pharmacist.
Oral administration.
Recommended dose: adults 1 to 2 capsules three times a day;
children over 12 years of age 1 capsule three times a day.
Swallow the capsules whole with a sufficient amount of liquid, e.g., a glass of water.
Take the medicine at regular intervals.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Taking a higher dose of Spasmolina than recommended

If you have taken a higher dose than recommended, stop taking the medicine and consult your doctor or pharmacist immediately.
No cases of overdose have been reported in humans.

Missing a dose of Spasmolina

Do not take a double dose to make up for a missed dose. Continue treatment as directed by your doctor.

Stopping treatment with Spasmolina

No symptoms have been observed when stopping treatment with Spasmolina.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Spasmolina can cause side effects, although not everybody gets them.
Mouth disorders
Unknown frequency: dry mouth feeling.
Circulatory system disorders
Unknown frequency: decrease in blood pressure.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Spasmolina

Store in a temperature below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Spasmolina contains

• The active substance of the medicine is alverine citrate (Alverini citras). One capsule contains 60 mg of alverine citrate.
• The other ingredients are: gelatin, sorbitol, magnesium stearate, titanium dioxide (E 171), quinoline yellow (E 104), orange yellow (E 110).

What Spasmolina looks like and what the packaging contains

Spasmolina is a hard capsule with a yellow-white color.
Packaging:
Aluminum/PVC blisters in a cardboard box.
20 capsules (2 blisters of 10 each)

Marketing authorization holder and manufacturer

Przedsiębiorstwo Farmaceutyczno-Chemiczne „Synteza” Sp. z o.o.
ul. Św. Michała 67/71
61-005 Poznań
tel. 61 879-20-81
To obtain more detailed information, please contact the local representative of the marketing authorization holder:
Polska
Przedsiębiorstwo Farmaceutyczno-Chemiczne „Synteza” Sp. z o.o.
ul. Św. Michała 67/71
61-005 Poznań
tel. 61 879-20-81

Date of the last update of the leaflet: