Bactrimel

Package leaflet: Information for the patient

Bactrimel 40 mg/ml + 8 mg/ml oral suspension

sulfamethoxazole and trimethoprim
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Bactrimel is and what it is used for
2. What you need to know before taking Bactrimel
3. How to take Bactrimel
4. Possible side effects
5. How to store Bactrimel
6. Contents of the pack and other information

1. What Bactrimel is and what it is used for

What Bactrimel is
Bactrimel is a combination of two substances: sulfamethoxazole and trimethoprim. Together, they destroy bacteria and prevent them from growing and reproducing.
What Bactrimel is used for
Bactrimel is mainly used for:

• urinary tract infections
• prostate infections
• lung infections that worsen over time
• infections such as dysentery, typhoid fever, and paratyphoid fever

Bactrimel may also be used for the prevention and treatment of a type of pneumonia caused by a yeast-like fungus called "Pneumocystis jirovecii". In this case, it is especially used in patients with a weakened immune system.

Bactrimel is used in adults and children aged 6 weeks and older.

2. What you should know before taking Bactrimel

Do not use Bactrimel:

• if you are allergic to trimethoprim, sulfamethoxazole, or any of the other ingredients of Bactrimel (see section 6 “Contents in the pack and other information”)
• if you have severe liver damage
• if you suffer from a serious blood disorder
• if your body is unable to break down glucose, or if you are breastfeeding a baby whose body cannot break down glucose
• if the child is less than 6 weeks old
• if you have severe renal failure
• if you are taking a medicine called dofetilide (used for heart rhythm problems)

Do not use Bactrimel if any of the above conditions apply to you. If you are unsure, consult your doctor before using Bactrimel.

Warnings and precautions
Talk to your doctor or pharmacist before taking Bactrimel:

• if you have kidney problems
• if you have low levels of folic acid
• if you are over 65 years old, malnourished, or severely dehydrated
• if you suffer from cystic fibrosis
• if you have a severe allergy or asthma
• if you have a thyroid gland disorder
• if your doctor has told you that your liver takes longer than normal to eliminate medicines
• if your doctor has told you that you have high potassium levels in your blood

Be alert to side effects
Stop treatment with Bactrimel and contact your doctor immediately if you notice any of the following side effects:

• Infection: Bactrimel may reduce your body's defences against infections (by affecting white blood cells). If you develop signs of infection, you must consult your doctor as soon as possible – see section 4, “Serious side effects”, for signs of infection.
• Potentially life-threatening skin reactions, such as: Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) – see section 4, “Serious side effects”, for signs of these conditions.
• Muscle pain, cramps, or weakness: stop taking Bactrimel and contact your doctor immediately if you experience any of the above symptoms. It is important to inform your doctor that you have taken Bactrimel.
• Cough and shortness of breath: if cough and shortness of breath worsen, inform your doctor immediately.
• Hemophagocytic lymphohistiocytosis: very rarely, excessive immune reactions due to uncontrolled activation of white blood cells causing inflammation (hemophagocytic lymphohistiocytosis) have been reported. These reactions can be life-threatening if not diagnosed and treated early. If you experience more than one symptom such as fever, swollen lymph nodes, feeling weak, dizziness, shortness of breath, bruising, or rash occurring simultaneously or in close succession, contact your doctor immediately.

Other medicines and Bactrimel
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. Bactrimel may affect how some medicines work. Also, some medicines may affect how Bactrimel works.
In particular, do not take Bactrimel if you are taking dofetilide, a medicine used for heart rhythm problems.
Tell your doctor or pharmacist if you are taking any of the following medicines:

• medicines for type 2 diabetes, such as: chlorpropamide, glibenclamide, repaglinide, pioglitazone, glipizide, tolbutamide, gliclazide, rosiglitazone
• memantine, amantadine (for dementia)
• warfarin, acenocoumarol, phenprocoumon (to thin the blood)
• ciclosporin, tacrolimus, azathioprine (medicines to suppress the immune system)
• prednisolone (anti-inflammatory)
• phenytoin (for epilepsy)
• digoxin, amiodarone (heart medicines)
• ACE inhibitors (for high blood pressure or heart failure)
• tricyclic antidepressants, clozapine (for mental health problems)
• oral contraceptive pill
• zidovudine and lamivudine (for HIV)
• diuretics such as thiazides, potassium-sparing diuretics (for high blood pressure or heart failure)
• methotrexate, paclitaxel, mercaptopurine (anticancer medicines)
• pyrimethamine (an antimalarial medicine)
• dapsone (for skin diseases)

Bactrimel may interfere with certain clinical laboratory tests. Inform your doctor that you are taking Bactrimel if you are told you need to undergo clinical tests while taking this medicine.
If any of the above points apply to you or if you are unsure, talk to your doctor or pharmacist before using Bactrimel.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine. There is a risk that the baby may be affected.
Ask your doctor or pharmacist if you are breastfeeding or planning to breastfeed. This is because small amounts of Bactrimel may pass to the baby.

Driving and using machines
Bactrimel is not expected to affect your ability to drive or operate machinery, although Bactrimel may cause dizziness, seizures, and hallucinations (see section 4).

Bactrimel contains sorbitol (E420), methyl 4-hydroxybenzoate (E218), propyl 4-hydroxybenzoate (E216), propylene glycol (E1520), alcohol (ethanol), and sodium.
Bactrimel contains 630 mg of sorbitol per ml, corresponding to 3 to 25 grams of sorbitol per day.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) are intolerant to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, consult your doctor before you (or your child) take this medicine.
Sorbitol may cause gastrointestinal problems and has a mild laxative effect.
Bactrimel contains methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate, which may cause an allergic reaction (including delayed reactions).
Bactrimel contains 24 mg of propylene glycol per 5 ml, equivalent to 4.8 mg/ml.
Bactrimel contains 9 mg of alcohol (ethanol) per 5 ml, equivalent to 1.8 mg/ml. The amount in 5 ml of this medicine is equivalent to less than 0.23 ml of beer or 0.10 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
Bactrimel contains less than 1 mmol (23 mg) of sodium per ml, making it essentially “sodium-free”.

3. How to take Bactrimel

Take Bactrimel exactly as prescribed by your doctor. Do not change the dose that has been prescribed for you. If you have any doubts, consult your doctor or pharmacist.
When to take Bactrimel
Bactrimel is supplied with a dosing spoon graduated at 1.25 ml, 2.5 ml and 5 ml. This dosing spoon can also be used to measure 2.5 ml (half a dosing spoon). Always use the dosing spoon provided when taking Bactrimel.
Take Bactrimel twice daily: once in the morning and once in the evening.
For oral use.
Shake the bottle well before each use.
Rinse the dosing spoon after each use.
How much to take
Standard dose for adults and children over 12 years of age:

• 20 ml (4 dosing spoons) of Bactrimel oral suspension, morning and evening

Standard dose for children aged 12 years or younger:

• aged 6 weeks to 5 months: 2.5 ml (half a dosing spoon) of oral suspension, morning and evening.
• aged 6 months to 5 years: 5 ml (1 dosing spoon) of oral suspension, morning and evening.
• aged 6 to 12 years: 10 ml (2 dosing spoons) of oral suspension, morning and evening.

Your treatment should continue until you have been symptom-free for 2 days and generally should not exceed 7 days. Contact your doctor if you do not feel better or if you feel worse after 7 days of treatment.
Your doctor may prescribe a different dosage or duration of treatment depending on your diagnosis and clinical condition. Always follow your doctor's instructions.
If you take more Bactrimel than you should
If you take more Bactrimel than you should, contact your doctor immediately or go to the nearest hospital.
Symptoms of overdose may include nausea, vomiting, diarrhoea, headache, dizziness, mental disturbances and visual disturbances. The doctor will provide appropriate supportive treatment to manage the symptoms of excessive dosage.
If you forget to take Bactrimel

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
• Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, Bactrimel can cause side effects, although not everyone gets them.

Serious side effects

Call emergency services immediately if you experience multiple symptoms such as fever, very low blood pressure, or increased heart rate after taking this medicine, as this may be a sign of collapse.

Stop treatment with Bactrimel and contact your doctor immediately if you experience any of the following:

• Potentially life-threatening skin reactions: (very rare frequency)
  o These skin reactions often begin with flu-like symptoms.
  o The risk is higher during the first weeks of treatment.
  o Signs of skin reactions include:
  • red to purple spots, target-like or round lesions with blisters in the center, often appearing symmetrically across the body. The skin may begin to peel.
  • sudden rash with the appearance of red pimple-sized pustules (acute generalized exanthematous pustulosis, AGEP)
  • mouth, throat, nose, or genital ulcers
  • eye inflammation (red, swollen eyes)

Do not use again any medicines containing trimethoprim or sulfamethoxazole if you experience any of the symptoms described above after taking Bactrimel.

• Muscle pain, cramps, or weakness (myalgia, frequency not known)
  o Unexplained muscle pain, cramps, or weakness.

• Severe infection: your doctor should perform a blood test as soon as possible to rule out a low white blood cell count (agranulocytosis, very rare frequency). Be alert for signs of:
  o infection with fever and general malaise
  o sore throat
  o mouth sores
  o urinary tract infection

• Severe allergic reaction (very rare frequency)
  o swelling of the face, tongue, or throat, difficulty swallowing, or hives and facial disturbances

Stop treatment with Bactrimel and contact your doctor immediately if you experience any of the symptoms listed above.

Other side effects

Tell your doctor, pharmacist, or nurse if you experience any of the following side effects:

Common: may affect up to 1 in 10 people

• feeling unwell or malaise
• blood tests showing liver or kidney problems
• inflamed skin or skin rash, redness, or itching

Uncommon: may affect up to 1 in 100 people

• fungal infections
• uncontrolled body movements (seizures)
• diarrhoea
• colitis
• inflamed liver (hepatitis)
• kidney failure
• urticaria

Rare: may affect up to 1 in 1,000 people

• blood disorders, such as low white blood cell count
• reduced blood sugar levels
• feeling weak, difficulty moving, blackouts (functional neurological disorders)
• inflamed tongue and mouth
• bile-related problems (cholestasis)
• crystals in the urine
• stomach pain

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

• lung problems such as cough, shortness of breath
• blood tests showing high levels of potassium in the blood
• hallucinations
• difficulty coordinating muscle movements
• inflamed eye
• dizziness
• allergic reaction with inflammation of the heart muscle (allergic myocarditis)
• ringing in the ears
• destruction of liver tissue (hepatic necrosis)
• increased urine production compared to usual or partial kidney inflammation
• meningitis
• light sensitivity (photosensitivity)
• inflamed blood vessels (vasculitis) affecting the whole body
• destruction of muscle tissue (rhabdomyolysis)

Not known: frequency cannot be estimated from the available data

• blood tests showing reduced sodium levels
• sudden inflammation of the pancreas (acute pancreatitis)
• injury to the bile ducts (vanishing bile duct syndrome)
• joint and muscle pain
• painful, raised, purple-colored sores on limbs and sometimes on the face and neck with fever (Sweet's syndrome)
• kidney stones (urolithiasis)

Your doctor may ask you to have blood tests while you are taking Bactrimel to monitor some of these side effects.

Tell your doctor, pharmacist, or nurse if you notice any of the side effects listed above.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Bactrimel

Keep this 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 that month.
After opening, do not store above 25 °C and use within 8 weeks.
Keep the dosing spoon with the product in the outer packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bactrimel contains

• The active substances are sulfamethoxazole and trimethoprim. 1 ml of Bactrimel oral suspension contains 40 mg of sulfamethoxazole and 8 mg of trimethoprim. One 5 ml dosing spoon of Bactrimel oral suspension contains 200 mg of sulfamethoxazole and 40 mg of trimethoprim.
• The other components are: sorbitol (sweetener E420), microcrystalline cellulose, sodium carmellose, methyl parahydroxybenzoate (preservative E218), propyl parahydroxybenzoate (preservative E216), polysorbate 80, banana flavour (containing propylene glycol E1520), vanilla flavour (containing ethanol), and purified water.

Description of the appearance of Bactrimel and contents of the pack
Glass bottle containing 100 ml of oral suspension
One transparent 5 ml plastic dosing spoon, graduated at 1.25 ml, 2.5 ml and 5 ml.
Marketing Authorisation Holder and Manufacturer
EUMEDICA Pharmaceuticals GmbH
Basler Straße 126
79540 Lörrach
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Sweden, France: Bactrim
Italy: Bactrimel
Medical advice/information

Antibiotics are used to treat infections of bacterial origin. They have no effect against viral infections.
Sometimes a bacterial infection does not respond to a course of antibiotic treatment. One of the most common reasons for this is that the bacteria causing the infection are resistant to the prescribed antibiotic. This means that they can survive and even multiply despite antibiotic therapy. Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the likelihood that bacteria will develop resistance to them.
When your doctor prescribes a course of antibiotics, it is intended solely to treat your current illness.
Following the advice below will help prevent the development of antibiotic-resistant bacteria, which could impair the effectiveness of antibiotics.

1. It is very important that you take the antibiotic exactly as prescribed, at the correct times and for the correct number of days. Read the instructions in the package leaflet and, if in doubt, ask your doctor or pharmacist for clarification.
2. Do not take an antibiotic unless it has been specifically prescribed for you, and use it only to treat the infection for which it was prescribed.
3. Do not take antibiotics that have been prescribed for other people, even if their infection seemed similar to yours.
4. Do not give antibiotics prescribed for you to other people.
5. If you have any antibiotic left over after completing the course prescribed by your doctor, return the remaining medicine to a pharmacy for proper disposal.