Package leaflet: Information for the patient

SPASMOLINA 120 mg, hard capsules
Alverini citras
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are identical.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Spasmolina is and what it is used for
Important information before taking Spasmolina
How to take Spasmolina
Possible side effects
How to store Spasmolina
Contents of the pack and other information

1. What Spasmolina is and what it is used for

Spasmolina contains the active substance alverine citrate, which has antispasmodic properties.
The mechanism of action of this medicine is primarily due to its direct relaxing effect on smooth
muscles of the gastrointestinal tract, biliary and urinary tracts, and uterus. This helps reduce pain
caused by muscle tension.
The medicine is used:

for symptomatic treatment of spastic conditions of the smooth muscles of the gastrointestinal tract, biliary and urinary tracts, and uterus;
as an antispasmodic in irritable bowel syndrome, painful colonic diverticulosis, and dysmenorrhea. Due to the lack of anticholinergic (atropine-like) effects, Spasmolina may be used in patients with glaucoma or benign prostatic hyperplasia.

2. Important information before using Spasmolina

When not to use Spasmolina:

if the patient is allergic to alverine citrate or any of the other ingredients of this medicine (listed in section 6);
if the patient has intestinal obstruction or the small intestine is not functioning properly;
in children under 12 years of age.

Warnings and precautions
Before starting treatment with Spasmolina, discuss it with your doctor or pharmacist.
Exercise particular caution when using Spasmolina:

if the patient has severe circulatory insufficiency;
if the patient has severe liver or kidney impairment.

Medical advice must be sought immediately if any of the following occur:

patients aged 40 years or older;
rectal bleeding;
nausea or vomiting;
loss of appetite or weight loss;
pallor and feeling of fatigue;
severe constipation;
fever;
recent travel abroad;
pregnancy or possible pregnancy;
abnormal vaginal bleeding or discharge;
difficulty or pain during urination.

Consult your doctor if new symptoms appear, if symptoms worsen, or if there is no improvement after two weeks of treatment.

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

Spasmolina and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription.
No interactions between Spasmolina and other medicines have been reported to date.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.

Pregnancy
Use of Spasmolina during pregnancy is not recommended unless otherwise directed by a doctor. The medicine may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding
Use of Spasmolina is not recommended during breastfeeding.

Driving and operating machinery
If dizziness occurs, do not drive or operate machinery.

3. How to use Spasmolina

This medicine should be taken exactly as described in this patient leaflet or as directed by a doctor.
If in doubt, consult a doctor or pharmacist.
Oral administration.
Recommended dose:
Adults (including elderly patients): 1 capsule up to three times daily.
Children and adolescents above 12 years of age: 1 capsule daily.
Spasmolina should not be used in children under 12 years of age.
Capsules should be swallowed whole with an adequate amount of liquid, e.g. a glass of water.
The medicine should be taken at regular intervals.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Taking more Spasmolina than recommended
If you take more than the recommended dose, stop taking the medicine and consult a doctor or pharmacist immediately.
In case of overdose, the following symptoms may occur: low blood pressure (hypotension) and symptoms similar to atropine poisoning (such as rapid heartbeat, dizziness, dry mouth, nausea, blurred vision, dilated pupils, confusion, and hallucinations).
The doctor will assess the patient's condition and decide on further treatment.
Missing a dose of Spasmolina
Do not take a double dose to make up for a missed dose. Continue treatment according to the dosage recommended by your doctor.
Stopping Spasmolina
No symptoms related to discontinuation of the medicine have been observed.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The frequency of the adverse reactions listed below is unknown (i.e. cannot be estimated from the available data).
If any of the following serious adverse reactions occur, discontinue use of the medicine and contact a doctor immediately:

severe and sudden allergic reaction (anaphylaxis);
low blood pressure;
shortness of breath and (or) wheezing;
jaundice caused by liver inflammation, abnormal liver function test results.

Other adverse reactions that may occur after administration of the medicine:

allergic reactions;
dizziness;
headache;
nausea;
dry mouth;
skin rash, itching.

If any of the above adverse reactions occur in a patient, a doctor should be notified immediately.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw,
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to obtain more information on the safety of the medicine.

5. How to store Spasmolina

There are no special requirements for storing this medicine.
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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Spasmolina contains

The active substance is alverine citrate (Alverini citras). One capsule contains 120 mg of alverine citrate.
The other ingredients are: gelatin, maize starch, magnesium stearate, titanium dioxide (E171), iron oxide black (E172), brilliant blue (E133).

What Spasmolina looks like and contents of the pack
Spasmolina is in the form of hard gelatin capsules size #0, with a grey cap and white body, filled with white or almost white powder.
Packaging:
PVC/Aluminium blisters in a cardboard box.
20 capsules (2 blisters containing 10 capsules each)

Marketing Authorisation Holder and Manufacturer
Przedsiębiorstwo Farmaceutyczno-Chemiczne „Synteza” Sp. z o.o.
ul. Św. Michała 67/71
61-005 Poznań
tel. 61 879-20-81

For further information, please contact the local representative of the Marketing Authorisation Holder:
Poland
Przedsiębiorstwo Farmaceutyczno-Chemiczne „Synteza” Sp. z o.o.
ul. Św. Michała 67/71
61-005 Poznań
tel. 61 879-20-81