SPAMILAN 5 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Spamilan, 5 mg, tablets
3. Spamilan, 10 mg, tablets
   1. You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Spamilan and what is it used for
5. Important information before taking Spamilan
   1. When not to take Spamilan
   2. Warnings and precautions
   3. Children and adolescents
   4. Spamilan and other medicines
   5. Taking Spamilan with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Spamilan contains lactose
6. How to take Spamilan
   1. Adults (including the elderly)
   2. Patients with mild or moderate liver and/or kidney function disorders
   3. Use in children and adolescents
   4. Taking a higher dose of Spamilan than recommended
   5. Missing a dose of Spamilan
   6. Stopping treatment with Spamilan
7. Possible side effects
   1. Very common (may occur in more than 1 in 10 patients):
   2. Common (may occur in up to 1 in 10 patients):
   3. Rare (may occur in up to 1 in 1,000 patients):
   4. Very rare (may occur in up to 1 in 10,000 patients):
   5. Reporting side effects
8. How to store Spamilan
9. Contents of the packaging and other information
   1. What Spamilan contains
   2. What Spamilan looks like and what the packaging contains
   3. Appearance
   4. Packaging
   5. Marketing authorization holder
   6. Manufacturer
   7. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Spamilan, 5 mg, tablets

Spamilan, 10 mg, tablets

Buspirone hydrochloride

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 you need to.
• 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 or pharmacist. 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 the patient is allergic to buspirone or any of the other ingredients of this medicine (listed in section 6);
• if the patient has epilepsy;
• if the patient has severe renal impairment (creatinine clearance <20 ml min 1.73 m or serum creatinine above 200 micromoles l);< li>
• if the patient has severe liver disease or has had it in the past;
• if the patient is in a state of acute alcohol intoxication, sedatives, painkillers, or antipsychotics (medicines 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 a benzodiazepine, such as nitrazepam or temazepam, or another commonly used sedative or sleeping pill. Before starting treatment with Spamilan, you should gradually stop taking these medicines.
• if you are taking certain antidepressants, mood-stabilizing medications, painkillers, medications for infections, migraines, severe pain, or opioid addiction (see "Spamilan and other medicines"). Taking some medications with Spamilan may lead to serotonin syndrome, which can be a life-threatening condition (see "Spamilan and other 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 under 18 years of age.

Spamilan and other medicines

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 to treat depression);
• Spamilan should not be taken with monoamine oxidase inhibitors due to the risk of increased blood pressure;
• erythromycin, itraconazole, linezolid, and rifampicin (used to treat infections);
• calcium antagonists, 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 to treat depression and anxiety disorders);
• nefazodone, trazodone, St. John's wort, L-tryptophan (used to treat depression);
• haloperidol and lithium (used to treat 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 tension);
• 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 (used to treat blood clots);
• phenobarbital, phenytoin, carbamazepine (used to treat epilepsy);
• buprenorphine (used to treat severe pain or opioid addiction).

Taking Spamilan with food, drink, and alcohol

While taking Spamilan, you should not drink alcohol.
While taking Spamilan, you should not drink grapefruit juice.

Pregnancy, breastfeeding, and fertility

In pregnancy and during breastfeeding, or if you suspect you are pregnant, or if you plan to become pregnant, you should consult a doctor or pharmacist before taking this medicine.
You should not take Spamilan during pregnancy and breastfeeding.

Driving and using machines

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

Spamilan contains lactose

Each Spamilan 5 mg tablet contains 55.7 mg of lactose monohydrate, and each Spamilan 10 mg tablet contains 111.4 mg of lactose monohydrate. If you have been diagnosed with intolerance to some sugars, you should contact 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 according to the doctor's or pharmacist's instructions. If you have any doubts, you should consult your doctor or pharmacist.
Your doctor will determine how many tablets to take per day and how often.
The tablets should be taken with water. The medicine should be taken every day at the same time, always with food or always without food.
Spamilan requires repeated administration: therapeutic effects do not appear earlier than within 7-14 days of treatment. To achieve maximum therapeutic benefit, treatment for 4 weeks may be necessary. Your doctor will decide how long you should take Spamilan.

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.

Patients with mild or moderate liver and/or kidney function disorders

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

Use in children and adolescents

The use of the medicine in children has not been established. There is a lack of data on the efficacy and safety of the medicine in children. Therefore, Spamilan is not recommended for use in children and adolescents.

Taking a higher dose of Spamilan than recommended

In case of taking a higher dose of the medicine than recommended, you should immediately inform your doctor or go to the nearest hospital. You should take all remaining tablets and this leaflet and show them to your doctor.
Symptoms of overdose are: nausea or vomiting, headaches, dizziness, drowsiness, ringing or buzzing in the ears, restlessness, sweating, tremors, chills, body temperature above 38°C, hallucinations (seeing or hearing things that do not exist), increased muscle tension, sudden involuntary rhythmic muscle contractions, including those affecting eye movements or rapid heartbeat.
The following may also occur: seizures, difficulty speaking or swallowing, loss of balance, mask-like face, gait with foot drag, stiffness of arms and legs, tremors of hands or fingers.

Missing a dose of Spamilan

In case of missing a dose, you should take the missed dose as soon as possible. You should not take the missed dose if it is almost time for the next dose. In this case, you should skip the missed dose and continue taking the medicine according to the prescribed schedule. You should not take a double dose to make up for the missed tablet.
The 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 recommendations.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should stop taking Spamilan and immediately consult your doctor if you experience symptoms of serotonin syndrome(confusion, agitation, coma, restlessness, sweating, tremors, chills, body temperature above 38°C, hallucinations, increased muscle tension, sudden involuntary rhythmic muscle contractions, including those affecting eye movements or rapid heartbeat).
If you experience any of the following symptoms, you should immediately consult your doctor or the emergency department of the nearest hospital:

• 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 occur in more than 1 in 10 patients):

dizziness, feeling of fainting, headaches, drowsiness.

Common (may occur in up to 1 in 10 patients):

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

Rare (may occur in up to 1 in 1,000 patients):

bruises (bruises), hives,

Very rare (may occur in up to 1 in 10,000 patients):

psychiatric disorders, hallucinations, depersonalization (feeling of strangeness), mood swings; seizures, tunnel vision, extrapyramidal disorders (difficulty speaking or swallowing, loss of balance, mask-like face, gait with foot drag, 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 affecting posture), fainting or fainting spells, memory loss, ataxia (difficulty controlling movements), parkinsonism (tremors, stiffness, and foot drag), akathisia (inability to sit or stand still), restless legs syndrome, 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 this leaflet, you should tell your doctor or pharmacist. 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
Phone: +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 25°C. Store in the original packaging to protect from light
Keep the medicine out of the reach and sight of children.
Do not use the medicine after the expiry date (EXP) stated on the packaging. The expiry date (EXP) means the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. You should 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 Spamilan contains

The active substance of the medicine is buspirone hydrochloride: each Spamilan 5 mg tablet contains 5 mg of buspirone hydrochloride, and each Spamilan 10 mg tablet contains 10 mg of buspirone hydrochloride.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), magnesium stearate, and anhydrous colloidal silica.

What Spamilan looks like and what the packaging contains

Appearance

Spamilan, 5 mg
White or almost white, round, flat tablets with beveled edges, with a dividing line on one side and a stylized E 151 mark on the other side.
The tablet can be divided into equal doses
Spamilan, 10 mg
White or almost white, round, flat tablets with a beveled edge, with a dividing line on one side and a stylized E 152 mark on the other side.
The tablet can be divided into equal doses.
.

Packaging

Blisters of OPA/Aluminum/PVC/Aluminum foil in a cardboard box.
60 tablets (6 blisters of 10 tablets each).

Marketing authorization holder

EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw

Manufacturer

EGIS Pharmaceuticals PLC

• H -1165 Budapest, Bökényföldi út 118-120 Hungary

To obtain more detailed information about this medicine, you should contact the representative of the marketing authorization holder.
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00

Date of last revision of the leaflet:

• 6.09.2024