AZITHROMYCIN JUBILANT 500 mg FILM-COATED TABLETS

2. What you need to know before you take Azithromycin Jubilant

Do not take Azithromycin Jubilant if:

• you are allergic (hypersensitive) to azithromycin dihydrate, erythromycin, or any of the other ingredients of this medicine (listed in section 6),
• you are allergic (hypersensitive) to any macrolide antibiotic.

Do not take this medicine if you have any of the above conditions. If you are not sure, consult your doctor or pharmacist before taking Azithromycin Jubilant.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine if:

• you have a liver disease: your doctor may need to monitor your liver function or stop treatment.
• you have a severe kidney disease.
• you have severe heart problems or irregular heartbeats, such as long QT syndrome (shown by an electrocardiogram or ECG equipment),
• you have low potassium or magnesium levels in your blood,
• you develop signs of another infection,
• you have neurological (nervous system) or psychiatric (mental health) problems.

Stop taking Azithromycin Jubilant and visit your doctor immediately if you notice any of the following serious side effects while taking this medicine:

• Swelling of the face, lips, tongue, or throat; difficulty breathing or swallowing; skin rash that can range from an itchy rash to severe blistering of the skin or ulcers on the lips, eyes, nose, mouth, and genitals. These signs could indicate a severe allergic reaction, angioedema, or anaphylaxis.
• Severe prolonged diarrhea or with blood and mucus. These signs could indicate a serious intestinal problem called pseudomembranous colitis.

Using Azithromycin Jubilant with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Inform your doctor or pharmacist if you are taking any of the following medicines:

• Antacids (used for heartburn or indigestion). Azithromycin Jubilant should be taken at least 1 hour before or 2 hours after the antacid.
• Ergotamine (used for migraines) should not be taken simultaneously, as serious side effects can occur (with numbness or tingling in the limbs, muscle cramps, headache, seizures, and chest or abdominal pain).
• Warfarin or similar medicines (used to thin the blood). Azithromycin Jubilant may make the blood thinner.
• Cisapride (used to treat stomach problems) should not be taken simultaneously, as it could cause serious heart problems (shown by an electrocardiogram or ECG equipment).
• Terfenadine (used to treat spring allergic rhinitis) should not be taken simultaneously, as it could cause serious heart problems (shown by an electrocardiogram or ECG equipment).
• Zidovudine or nelfinavir (used to treat HIV infections). Taking nelfinavir with Azithromycin Jubilant may increase the occurrence of the side effects mentioned in this leaflet.
• Rifabutin (used to treat tuberculosis [TB]).
• Quinidine (used to treat heart rhythm disorders).
• Cyclosporin (used to prevent organ transplant rejection). Your doctor will regularly monitor the cyclosporin concentration in your blood and may adjust your dose.

Tell your doctor or pharmacist if you are taking any of the following medicines, as Azithromycin Jubilant may enhance their effects. Your doctor may adjust the dose:

• Triazolam, midazolam (sedatives)
• Alfentanil, an analgesic used, for example, during operations
• Theophylline (used for respiratory problems such as asthma and chronic obstructive pulmonary disease [COPD])
• Digoxin (used for heart failure treatment)
• Colchicine (used for gout and familial Mediterranean fever)
• Astemizole (used to treat spring allergic rhinitis)
• Pimozide (used to treat mental health disorders)

Taking Azithromycin Jubilant with food and drinks

This medicine can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Azithromycin is not recommended during pregnancy or if you are planning to become pregnant, or if you are breastfeeding. Azithromycin should only be used during pregnancy when clearly necessary.

This medicine passes into breast milk. Therefore, you should stop breastfeeding until two days after you have finished taking this medicine. You can talk to your doctor about pumping and discarding your milk during this time or using another antibiotic.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

If the medicine makes you feel dizzy or you experience any other effect that affects your ability to concentrate, do not drive or operate machinery.

Azithromycin Jubilant contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Azithromycin Jubilant

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

Taking this medicine

• Swallow the tablets whole with a glass of water.
• Do not crush or chew the tablets.
• The 500 mg tablet can be divided into two equal halves.

How much to take

Adults and adolescents with a body weight of 45 kg or more:

The usual total dose is 1,500 mg. This can be taken in two ways. Your doctor will tell you which one to follow:

• For three days: one 500 mg tablet each day.

or

• For five days: one 500 mg tablet on day 1 and then one 250 mg tablet on days 2, 3, 4, and 5.

The dose varies if you have inflammation of the tube through which urine leaves the bladder (urethra) or the area where the uterus connects with the vagina (cervix). Your doctor will tell you to take a single dose of 1,000 mg.

Children and adolescents who weigh less than 45 kg:

These tablets are not recommended. Young people with a body weight below 45 kg should take this medicine in other forms, such as azithromycin suspension.

Patient with kidney or liver problems

Tell your doctor if you have kidney or liver problems, as you may need to adjust the normal dose.

If you take more Azithromycin Jubilant than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. The following effects may occur:

• temporary hearing loss,
• feeling dizzy (severe nausea), vomiting, and diarrhea.

If you forget to take Azithromycin Jubilant

• If you miss a dose, take it as soon as you remember.
• However, if it is almost time for your next dose, do not take the missed dose.
• Do not take a double dose to make up for a forgotten dose.
• Even if you miss a dose, take all the tablets. This means you will finish the treatment cycle one day later than planned.

If you stop taking Azithromycin Jubilant

Do not stop treatment with azithromycin without first talking to your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Azithromycin Jubilant can cause side effects, although not everybody gets them.

Stop taking Azithromycin Jubilant and visit your doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

• swelling of the face, lips, tongue, or throat; difficulty breathing or swallowing; skin rash that can range from an itchy rash to severe blistering of the skin or ulcers on the lips, eyes, nose, mouth, and genitals. These signs could indicate a severe allergic reaction, angioedema, or anaphylaxis.
• severe prolonged diarrhea or with blood or mucus. These signs could indicate a serious intestinal problem called pseudomembranous colitis.
• fever, red spots on the skin, blisters or peeling of the skin, joint pain, and swollen eyes. These signs could indicate a severe reaction such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme.

Other side effects include:

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

• diarrhea

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

• headache
• vomiting, abdominal pain, nausea
• change in the number of white blood cells and bicarbonate concentration in the blood

Uncommon: (may affect up to 1 in 100 people)

• thrush (candidiasis), yeast infections, especially in the mouth
• vaginal infections
• lung infection (pneumonia)
• fungal infection
• bacterial infection
• throat inflammation (pharyngitis)
• stomach and intestine inflammation (gastroenteritis)
• runny nose, sneezing (rhinitis)
• reduction in the number of white blood cells
• hypersensitivity
• loss of appetite (anorexia)
• nervousness
• difficulty sleeping (insomnia)
• feeling dizzy
• feeling drowsy
• tingling or numbness (paresthesia)
• changes in taste and smell (dysgeusia)
• vision changes
• ear disorders
• palpitations
• flushing
• breathing difficulties
• nosebleeds
• gastritis
• constipation
• flatulence
• digestive problems (dyspepsia)
• difficulty swallowing (dysphagia)
• abdominal distension
• dry mouth
• belching
• excessive saliva production
• liver problems, such as hepatitis or jaundice
• hives
• skin inflammation
• dry skin
• increased sweating
• joint swelling, cracking, and stiffness
• muscle pain
• back pain
• neck pain
• pain while urinating
• kidney pain
• light menstrual bleeding at irregular intervals
• testicular pain and swelling
• inflammation (edema)
• general malaise
• weakness
• fatigue
• chest pain
• pain
• skin swelling
• changes in liver enzyme values and blood values
• abnormal kidney function test results, potassium anomalies in the blood, sugar concentration anomalies in the blood
• post-procedure complications

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

• feeling nervous
• abnormal liver function
• cholestatic jaundice
• allergic skin reactions
• sensitivity to sunlight
• skin rash characterized by the rapid appearance of red skin areas dotted with small pus-filled bumps (small blisters).

Frequency not known: (cannot be estimated from the available data)

• decrease in the number of red blood cells due to destruction (hemolytic anemia); reduction in the number of platelets (thrombocytopenia)
• anaphylactic reaction
• feeling furious and aggressive
• anxiety
• delirium
• seeing, feeling, or hearing things that do not exist (hallucinations)
• fainting (syncope)
• seizures (convulsions)
• decreased sense of touch (hypoesthesia)
• feeling overactive
• smell disorders (anosmia, parosmia)
• taste disorders (ageusia)
• worsening of myasthenia gravis
• hearing loss or ringing in the ears
• rapid or irregular heartbeats, sometimes potentially fatal; changes in heart rhythm determined by an electrocardiogram
• low blood pressure
• pancreatitis (inflammation of the pancreas)
• changes in tongue color
• liver inflammation
• allergic skin reactions
• joint pain
• kidney problems
• heart rhythm disorders, known as QT interval prolongation

The following side effects have been reported in the prophylactic treatment of Mycobacterium Avium complex (MAC)

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

• diarrhea
• abdominal pain
• nausea
• flatulence
• abdominal discomfort
• diarrhea

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

• loss of appetite (anorexia)
• feeling dizzy
• headache
• tingling or numbness (paresthesia)
• changes in taste
• vision changes
• deafness
• skin rash and itching
• joint pain (arthralgia)
• fatigue

Uncommon: (may affect up to 1 in 100 people)

• decreased sense of touch (hypoesthesia)
• hearing loss or ringing in the ears
• palpitations
• liver problems, such as hepatitis
• Stevens-Johnson syndrome
• allergic skin reactions such as sensitivity to sunlight, red skin, scaly skin, and skin swelling
• general malaise
• weakness (asthenia)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Azithromycin Apotex

• Keep this medicine out of the sight and reach of children.
• This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any leftover medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and leftover medicines. This will help protect the environment.

6. Package Contents and Additional Information

Azitromicina Jubilant Composition

The active ingredient is Azitromicina (in the form of dihydrate).

The film-coated Azitromicina Jubilant 500 mg tablets contain azitromicina dihydrate equivalent to 500 mg of azitromicina.

The other components are:

Tablet core:

anhydrous calcium hydrogen phosphate, hypromellose (E464), sodium croscarmellose, magnesium stearate (E470b), pregelatinized corn starch, sodium lauryl sulfate.

Tablet coating:

hypromellose (E464), lactose monohydrate, titanium dioxide (E171), triacetin.

Product Appearance and Package Contents

Azitromicina Jubilant 500 mg is presented in the form of white to off-white film-coated tablets with a capsule shape, which are engraved with "AZ" and "500" on either side of the score line on one face; the other face is smooth.

The film-coated tablets are presented in blister packs of 2, 3, 6 or 30 tablets. Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Jubilant Pharmaceuticals nv

Axxes Business Park

Guldensporenpark 22 – Block C

9820 Merelbeke

Belgium

Manufacturer:

PSI supply nv

Axxes Businesspark

Guldensporenpark 22 – Block C

9820 Merelbeke

Belgium

Or

Galex d.d.

Tišinska ulica 29g

9000 Murska Sobota

Slovenia

Or

PharmaS d.o.o.

Industrijska cesta 5,

Potok, Popovaca, 44317,

Croatia

Date of Last Revision of this Leaflet: July 2018

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.