Spamilan

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Spamilan(Spitomin 10 mg) , 10 mg, tablets
Buspirone hydrochloride
Spamilan and Spitomin 10 mg are different trade names for the same drug.

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• You should consult a doctor or pharmacist if you have any further doubts.
• 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 you experience any side effects, including those not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Spamilan and what is it used for

Buspirone, the active substance of Spamilan, has an anxiolytic effect.
Spamilan is indicated for the short-term treatment of anxiety disorders and alleviation of symptoms
of anxiety with or without depression.

2. Important information before taking Spamilan

When not to take Spamilan

• if you are allergic to buspirone or any of the other ingredients of this medicine (listed in section 6);
• if you have epilepsy;
• if you have severe renal impairment (creatinine clearance <20 ml min 1.72 m or serum creatinine above 200 micromol l);< li>
• if you have severe liver disease or have had it in the past;
• if you are in a state of acute alcohol intoxication, taking sedatives, painkillers, or antipsychotics (drugs used to treat certain mental illnesses).

Warnings and precautions

Before starting treatment with Spamilan, you should consult a doctor or pharmacist:

• if you have glaucoma;
• if you have myasthenia (a disease characterized by muscle weakness, difficulty chewing, or slurred speech);
• if you are addicted to drugs or narcotics;
• if you have liver and/or kidney function disorders (see also "How to take Spamilan");
• if you have taken benzodiazepines, such as nitrazepam or temazepam, or other commonly used sedatives or sleeping pills. Before starting treatment with Spamilan, you should gradually stop taking these medicines.

Your doctor may recommend laboratory tests before starting treatment with Spamilan.
You should inform your doctor about any concomitant diseases that you have and that your doctor may not be aware of.

Children and adolescents

Spamilan is not recommended for use in children and adolescents.

Other medicines and Spamilan

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, you should tell your doctor if you are taking:

• monoamine oxidase inhibitors, such as moclobemide and selegiline (used in depression); Spamilan should not be taken at the same time as monoamine oxidase inhibitors due to the risk of increased blood pressure;
• erythromycin, itraconazole, linezolid, and rifampicin (used to treat infections);
• calcium channel blockers, such as diltiazem and verapamil (used to treat high blood pressure);
• selective serotonin reuptake inhibitors, such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline (used in depression and anxiety disorders);
• nefazodone, trazodone, St. John's wort, L-tryptophan (used in depression);
• haloperidol and lithium (used in mental illnesses);
• digoxin (used to treat heart failure);
• medicines that reduce stomach acid secretion containing cimetidine (used to treat stomach ulcers and heartburn);
• tramadol (a painkiller);
• triptans, such as sumatriptan (used to treat migraines);
• baclofen (used to treat increased muscle tone);
• lofexidine (used to treat withdrawal syndrome);
• nabilone (used to treat nausea and vomiting);
• antihistamines (used to treat allergic reactions);
• diazepam (used to treat anxiety);
• warfarin (a blood thinner);
• phenobarbital, phenytoin, carbamazepine (used to treat epilepsy).

Taking Spamilan with food, drink, and alcohol

You should not drink alcohol while taking Spamilan.
You should not drink grapefruit juice while taking Spamilan.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not take Spamilan during pregnancy and breastfeeding.

Driving and using machines

Spamilan may have a moderate influence on the ability to drive and use machines.
It may cause drowsiness or dizziness. Before driving or operating machinery, you should make sure that these symptoms do not occur.
Due to the possibility of transient side effects at the start of treatment, you should not drive or operate machinery until you are sure that the medicine does not affect your ability to drive or operate machinery.

Spamilan contains lactose

Each Spamilan 10 mg tablet contains 111.4 mg of lactose.
If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Spamilan

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Your doctor will decide how many tablets to take per day and how often.
Spamilan is available in the following strengths: 5 mg, 10 mg.
The tablets should be taken with water. The medicine should be taken daily at the same time, always with or always without food.

Adults (including the elderly)

The recommended initial dose is 5 mg twice or three times a day and can be increased every 2-3 days.
The usual therapeutic dose is 15 to 30 mg per day in divided doses.
The maximum daily dose is 60 mg in divided doses.

Patient with mild or moderate liver and/or kidney impairment

In patients with mild or moderate liver and/or kidney impairment, the doctor may recommend a lower dose of the medicine.

Use in children and adolescents

The use of Spamilan in children has not been established. There is no data on the efficacy and safety of the medicine in children. Therefore, Spamilan is not recommended for use in children and adolescents.

Overdose of Spamilan

In case of overdose, you should immediately inform your doctor or go to the nearest hospital. You should take all remaining tablets and this leaflet with you and show them to your doctor.
Symptoms of overdose are: nausea or vomiting, headaches, dizziness, drowsiness, ringing or buzzing in the ears, restlessness, pinpoint pupils, stomach upset, slow heartbeat, low blood pressure, seizures, and extrapyramidal symptoms (difficulty speaking or swallowing, loss of balance, mask-like face, gait disturbance, stiffness of arms and legs, tremors of hands and fingers).

Missed dose of Spamilan

If you miss a dose, you should take it as soon as possible. Do not take a missed dose if it is almost time for your next dose. In this case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed tablet.
Tablets should be taken as often and for as long as your doctor recommends.

Stopping treatment with Spamilan

You should not stop treatment on your own, even if you do not notice any improvement in your condition. Before stopping treatment, you should consult your doctor and follow their advice.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Spamilan can cause side effects, although not everybody gets them.
You should stop taking Spamilan and contact your doctor immediately if you are taking selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine or paroxetine, and have: serotonin syndrome(feeling confused, restlessness, sweating, shivering, hallucinations (seeing or hearing things that do not exist), sudden muscle contractions or rapid heartbeat.
If you experience any of the following symptoms, you should contact your doctor or the emergency department of your nearest hospital immediately:

• swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing;
• fainting;
• itching skin rash. These are very serious side effects caused by an allergic reaction to Spamilan and may require urgent medical attention and intensive hospital treatment. The following side effects have also been reported:

Very common (may affect more than 1 in 10 people):

dizziness, feeling faint, headaches, drowsiness.

Common (may affect up to 1 in 10 people):

nervousness, insomnia, concentration disorders, depression, confusion, sleep disorders, irritability;
paresthesia (numbness or tingling), blurred vision, coordination disorders, tremors, tinnitus (ringing in the ears); rapid heartbeat, chest pain; nausea, stomach pain, dry mouth, diarrhea, constipation, vomiting; cold sweats, rash; muscle, tendon, and bone pain; fatigue (tiredness).

Rare (may affect up to 1 in 1000 people):

bruising (bruises), hives.

Very rare (may affect up to 1 in 10,000 people):

psychiatric disorders, hallucinations, depersonalization (feeling of being a stranger to oneself), mood swings; seizures, tunnel vision, extrapyramidal symptoms (difficulty speaking or swallowing, loss of balance, mask-like face, gait disturbance, stiffness of arms and legs, tremors of hands or fingers), muscle stiffness with cogwheel phenomenon (jerky movements), dyskinesia (involuntary movements), dystonia (muscle contractions of the neck, shoulders, and body that affect posture), fainting or fainting spells, memory loss, ataxia (difficulty controlling movements), parkinsonism (tremors, stiffness, and shuffling gait), akathisia (inability to sit or stand still), restless legs syndrome, restlessness; inability to fully or partially empty the bladder; excessive milk production.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Spamilan

Store in a temperature below 30°C, in the original packaging.
Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Spamilan contains

Each Spamilan tablet contains 10 mg of buspirone hydrochloride as the active substance.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), magnesium stearate, and colloidal silica.

What Spamilan looks like and contents of the pack

Appearance

White or almost white, round, flat tablets with beveled edges and a score line engraved on one side and the letter E and the number 152 engraved on the other side.
The score line on the tablet is only to facilitate breaking and not to divide into equal doses.

Packaging

60 tablets in blister packs, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer:

Egis Pharmaceuticals PLC
Bökényföldi út 118-120
1165 Budapest
Hungary

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Romania, the country of export:12677/2019/01
Parallel import authorization number:531/12
Date of leaflet approval: 02.09.2022
[Information about the trademark]