Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Spamilan (Spitomin 10 mg) , 10 mg, tablets
Buspironi hydrochloridum
Spamilan and Spitomin 10 mg are different brand names of the same medicine.
Please read the entire leaflet before using the medicine, as it contains important information for the patient.

Keep this leaflet so that you can read it again if necessary.
Consult your doctor or pharmacist if you have any further questions.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

What Spamilan is and what it is used for
What you need to know before taking Spamilan
How to take Spamilan
Possible side effects
How to store Spamilan
Contents of the pack and other information

1. What Spamilan is and what it is 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 has epilepsy;
if the patient has severe renal impairment (creatinine clearance < 20 ml/min/1.72 m² or plasma creatinine concentration above 200 micromoles/l);
if the patient currently has or has ever had severe liver disease;
if the patient is in a state of acute intoxication with alcohol, hypnotics, 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 (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 take Spamilan");
if the patient has previously taken a benzodiazepine medicine, e.g. nitrazepam or temazepam, or another commonly used sedative or hypnotic medicine. Before starting treatment with Spamilan, such medicines should be gradually withdrawn.

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.
Other medicines and Spamilan
Tell your doctor about all medicines currently taken or taken recently, as well as any medicines the patient plans to use.
In particular, inform your doctor about taking the following medicines:

monoamine oxidase inhibitors, such as moclobemide and selegiline (used in depression); Spamilan should not be used concomitantly with monoamine oxidase inhibitors due to the risk of increased blood pressure;
erythromycin, itraconazole, linezolid and rifampicin (used in the treatment of infections);
calcium antagonists, such as diltiazem and verapamil (used in the treatment of 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 preparations, L-tryptophan (used in depression);
haloperidol and lithium (used in mental disorders);
digoxin (used in the treatment of heart failure);
medicines reducing gastric acid secretion containing cimetidine (used in the treatment of gastric ulcers and heartburn);
tramadol (analgesic);
triptans, e.g. sumatriptan (used in the treatment of migraine);
baclofen (used in increased muscle tone);
lofexidine (used in the treatment of withdrawal syndrome);
nabilone (used in the treatment of nausea and vomiting);
antihistamines (used in the treatment of allergic reactions);
diazepam (used in the treatment of anxiety);
warfarin (a blood-thinning medicine);
phenobarbital, phenytoin, carbamazepine (antiepileptic medicines).

Taking Spamilan with food, drink and alcohol
Do not drink alcohol during treatment with Spamilan.
Do not drink grapefruit juice during treatment with Spamilan.
Pregnancy, breastfeeding and fertility
During pregnancy and 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 operating machinery
Spamilan has a moderate effect on the ability to drive and operate 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 possibility of transient adverse effects at the beginning of treatment, driving and operating machinery should be avoided until it is confirmed that the medicine has no undesirable effect on the ability to drive and operate machinery.
Spamilan contains lactose
Each 10 mg Spamilan tablet contains 111.4 mg of 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, meaning the medicine is considered "sodium-free".

3. How to take Spamilan

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Your doctor will determine how many tablets you should take per day and how often.
Spamilan is available in the following doses: 5 mg, 10 mg.
Tablets should be taken with water. The medicine should be taken every day at the same time, always with
food or always without food.
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
In patients with mild or moderate liver and/or kidney function disorders, your doctor may recommend a lower dose.
Use in children and adolescents
The use of this medicine in children has not been established. There is lack of data regarding the efficacy and safety of Spamilan in children.
Therefore, the use of Spamilan is not recommended in children and adolescents.
Taking more Spamilan than prescribed
If you take more Spamilan than you should, contact your doctor immediately or go to the nearest hospital.
You should 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 heartbeat, low blood pressure, seizures, and extrapyramidal symptoms
(difficulty speaking or swallowing, loss of balance, mask-like face, shuffling gait, stiffness of arms and legs, tremor of hands and fingers).
If you miss a dose of Spamilan
If you miss a dose, take it as soon as possible. Do not take the 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.
Take the tablets as often and for as long as your doctor has instructed.
Stopping Spamilan
Do not stop treatment on your own, even if you do not notice any improvement in your health. Before stopping the medicine,
you should 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 all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You should stop taking Spamilan and contact your doctor immediately if the patient is also taking selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine or paroxetine, and experiences: serotonin syndrome (confusion, restlessness, sweating, tremors, shivering, hallucinations (seeing or hearing things that are not real), sudden muscle spasms, or rapid heartbeat).

If any of the following symptoms occur, contact your doctor or go to 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 patients):
dizziness, feeling faint, headache, drowsiness.

Common (may affect up to 1 in 10 patients):
nervousness, insomnia, difficulty concentrating, depression, confusion, sleep disturbances, irritability;
paraesthesia (numbness or tingling), blurred vision, movement coordination disorders, tremor, tinnitus (ringing in the ears); increased heart rate, 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 patients):
petechiae (bruising), urticaria.

Very rare (may affect up to 1 in 10,000 patients):
psychiatric disorders, hallucinations, depersonalization (feeling of self-estrangement), emotional 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 tremors), muscle rigidity with cogwheel phenomenon (interrupted movements), dyskinesias (involuntary movements), dystonia (muscle spasms in the neck, shoulders and body affecting posture), fainting or repeated fainting, 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 fully 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, pharmacist or nurse. 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 the medicine Spamilan

Store below 30°C, in the original packaging.
Keep the medicine out of 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

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

What Spamilan looks like and contents of the pack
Appearance
White or almost white, round, flat tablets with bevelled edges, imprinted with a breakline on one side and the letter E and number 152 on the other side.
The breakline on the tablet is intended only to facilitate crushing for easier swallowing, not for dividing into equal doses.

Packaging
60 tablets in blister packs, contained in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Romania, 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
Poland

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

Marketing Authorisation Number in Romania, country of export: 12677/2019/01
Parallel Import Licence Number: 531/12