Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging is in a foreign language.
Spamilan (Spitomin), 5 mg, tablets
Buspironi hydrochloridum
Spamilan and Spitomin are different trade names of the same medicinal product.
Please read the entire leaflet before using the medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
Consult your doctor or pharmacist if you have any further questions.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
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 is Spamilan and what is it used for
Important information before taking Spamilan
How to take Spamilan
Possible side effects
How to store Spamilan
Contents of the pack and other information

1. What is Spamilan and what is it used for

Buspirone, the active substance in Spamilan, has anxiolytic properties.
Spamilan is indicated for the short-term treatment of anxiety disorders and for the relief of anxiety symptoms, with or without accompanying depression.

2. Important information before using Spamilan

When not to use Spamilan

if the patient is allergic to buspirone or any of the other ingredients of this medicine (listed in section 6);
if the patient suffers from epilepsy;
if the patient has severe renal impairment (creatinine clearance < 20 mL/min/1.73 m² or serum creatinine concentration above 200 micromoles/L);
if the patient has or has ever had severe liver disease;
if the patient is in a state of acute intoxication with alcohol, sedatives, analgesics, or antipsychotics (medicines used in the treatment of certain mental disorders).

Warnings and precautions
Before starting treatment with Spamilan, consult a doctor or pharmacist

if the patient has glaucoma;
if the patient has myasthenia gravis (a disease characterized by muscle weakness, difficulty chewing, or slurred speech);
if the patient is addicted to drugs or narcotics;
if the patient has impaired liver and/or kidney function (see also section "How to use Spamilan");
if the patient has previously been taking a benzodiazepine medicine, e.g. nitrazepam or temazepam, or another commonly used sedative or hypnotic. Before starting treatment with Spamilan, these medicines should be gradually discontinued.
if the patient is taking certain antidepressants, mood-stabilizing normothymic agents, analgesics, or medicines used to treat infections, migraine, severe pain, or opioid dependence (see "Spamilan with other medicines"). Taking certain medicines together with Spamilan may lead to serotonin syndrome, which may be a potentially life-threatening condition (see "Spamilan with other medicines").

The treating physician may recommend laboratory tests before starting treatment with Spamilan.
Inform the treating physician about any concomitant medical conditions the patient may have that the physician might not be aware of.
Children and adolescents
Spamilan is not recommended for use in children and adolescents under 18 years of age.
Spamilan with other medicines
Tell your doctor about all medicines currently used, recently used, or planned for use.
In particular, inform your doctor if you are taking the following medicines:

monoamine oxidase inhibitors, such as moclobemide and selegiline (used to treat depression);
Spamilan must not be used concomitantly with 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 to treat depression and anxiety disorders);
nefazodone, trazodone, St. John's wort preparations, L-tryptophan (used to treat depression);
haloperidol and lithium (used to treat psychiatric disorders);
digoxin (used to treat heart failure);
medicines reducing gastric acid secretion containing cimetidine (used to treat gastric ulcers and heartburn);
tramadol (an analgesic);
triptans, e.g. sumatriptan (used to treat migraine);
baclofen (used for 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 (used to treat blood clots);
phenobarbital, phenytoin, carbamazepine (used to treat epilepsy);
buprenorphine (used to treat severe pain or opioid dependence).

Taking Spamilan with food, drink, and alcohol
Do not drink alcohol while taking Spamilan.
Do not drink grapefruit juice while taking Spamilan.
Pregnancy, breastfeeding, and fertility
During pregnancy, while breastfeeding, or if pregnancy is suspected or planned, consult a doctor or pharmacist before using this medicine.
Do not take Spamilan during pregnancy or while breastfeeding.
Driving and using machines
Spamilan has a moderate effect on the ability to drive and use machinery.
It may cause drowsiness or dizziness. Before driving or operating machinery, the patient should ensure that such symptoms do not occur.
Due to the possible occurrence of transient adverse effects at the beginning of treatment, driving and operating machinery should be avoided until it is confirmed that Spamilan does not adversely affect the ability to drive and operate machinery.
Spamilan contains lactose
Each Spamilan 5 mg tablet contains 55.7 mg of monohydrate lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Spamilan

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult your
attending physician or pharmacist.
Your attending physician will determine how many tablets to take per day and how often.
Tablets should be taken with water. The medicine should be taken daily at the same time, always
with food or always without food.
Spamilan requires repeated administration: therapeutic effects do not appear earlier than within
approximately 7–14 days of treatment. To achieve maximum therapeutic benefit, treatment for
4 weeks may be necessary. Your attending physician will decide how long you should continue taking
Spamilan.

Adults (including elderly patients)
The recommended initial dose is 5 mg two or three times daily, which may 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 hepatic and/or renal impairment
For patients with mild or moderate impairment of liver and/or kidney function, the physician may
recommend a lower dose.

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

Taking more than the recommended dose of Spamilan
If an overdose is taken, contact a doctor immediately or go to the nearest hospital. Bring all
remaining tablets together with this leaflet and show them to the doctor.
Symptoms of overdose include: nausea or vomiting, headache, dizziness, drowsiness, ringing or
buzzing in the ears, motor restlessness, constricted pupils, stomach disturbances.
Slow heart rate and low blood pressure may also occur.
Additional symptoms may include: seizures, difficulty speaking or swallowing, loss of balance,
mask-like facial expression, shuffling gait, stiffness of arms and legs, tremor of hands and fingers.

Missed dose of Spamilan
If a dose is missed, take it as soon as possible. Do not take the missed dose if it is almost time for
the next scheduled dose. In that case, skip the missed dose and continue with the regular dosing
schedule. Do not take a double dose to make up for a missed tablet.
Take the tablets as often and for as long as directed by your attending physician.

Stopping treatment with Spamilan
Do not stop treatment on your own, even if you do not notice any improvement in your health.
Before stopping the medicine, talk to your doctor and follow their instructions.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone experiences them.
You should stop taking Spamilan and contact your doctor immediately if
the patient experiences symptoms of serotonin syndrome (confusion, agitation, coma, restlessness,
sweating, tremors, chills, body temperature above 38°C, hallucinations (seeing or hearing
non-existent things), increased muscle rigidity, sudden involuntary rhythmic muscle contractions,
including muscles controlling eye movements, or rapid heartbeat).
If any of the following symptoms occur, contact your attending physician or the nearest hospital emergency department immediately:

swelling of the face, lips, tongue or throat, difficulty breathing or swallowing;
fainting;
itchy skin rash. These are very serious adverse reactions caused by hypersensitivity to Spamilan and may require urgent medical attention and intensive hospital treatment.

The following adverse reactions have also been reported:
Very common (may affect more than 1 in 10 people):
dizziness, feeling faint, headache, drowsiness.
Common (may affect up to 1 in 10 people):
nervousness, insomnia, difficulty concentrating, depression, confusion, sleep disturbances, irritability;
paraesthesia (numbness or tingling), blurred vision, coordination disorders, tremor,
tinnitus (ringing in the ears); rapid heartbeat, chest pain; nausea, abdominal pain, dry mouth, diarrhoea, constipation, vomiting; cold sweats, rash; muscle, tendon, ligament and bone pain; fatigue (tiredness).
Rare (may affect up to 1 in 1,000 people):
purpura (bruising), urticaria,
Very rare (may affect up to 1 in 10,000 people):
psychiatric disorders, hallucinations, depersonalization (feeling of self-alienation), affective lability; seizures, tunnel vision, extrapyramidal disorders (difficulty speaking or swallowing, loss of balance, mask-like face, shuffling gait, stiffness of arms and legs, hand or finger tremor), muscle rigidity with cogwheel phenomenon (interrupted movements), dyskinesia (involuntary movements), dystonia (spasms of neck, shoulder and trunk muscles affecting posture), fainting or loss of consciousness, memory loss, ataxia (difficulty controlling movements), parkinsonism (tremor, stiffness and shuffling gait), akathisia (inability to sit or stand still), restless legs syndrome, motor restlessness; inability to completely or partially empty the bladder; excessive milk production.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Spamilan

Do not store above 30°C. Keep in the original packaging to protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Spamilan contains
The active substance is buspirone hydrochloride: each tablet contains 5 mg of buspirone hydrochloride.
Other components: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch (type A), magnesium stearate, and colloidal anhydrous silica.

What Spamilan looks like and contents of the pack
Appearance
White or almost white, round, flat tablets with bevelled edges, marked with a division line on one side and a stylized symbol E 151 on the other side.
The tablet can be divided into equal doses.

Pack
Blister packs made of OPA/Al/PVC//Al foil in a cardboard box.
60 tablets (6 blisters containing 10 tablets each).

For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Hungary, country of export:
Egis Gyógyszergyár Zrt., H-1106 Budapest, Keresztúri út 30-38., Hungary

Manufacturer:
Egis Gyógyszergyár Zrt., H-1165 Budapest, Bökényföldi út 118-120., Hungary

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation Number in Hungary, country of export: OGYI-T-06315/01
Parallel Import Authorisation Number: 99/20