Mac Excellenta

Read all of this leaﬂet carefully before you start taking this medicine because it contains important information for
you.
– Keep this leaﬂet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. See sectio 4.

What is in this leaflet

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

1. What Mac Excellenta is and what it is used for
Mac Excellenta contains the active substance dexlansoprazole, which is a proton pump inhibitor (PPI). PPIs reduce the
amount of acid that your stomach makes.

Mac Excellenta is used in adults for the following:
– Treatment of erosive reflux oesophagitis (inflammation with damage to the lining of the oesophagus ( food
pipe))
– Maintenance of healed erosive reflux oesophagitis and maintenance of relief of heartburn
– Short-term treatment of heartburn and acid regurgitation associated with symptomatic non-erosive
gastro-oesophageal reflux disease (GORD). GORD is a condition where stomach acid leaks out of the stomach and
comes up into the oesophagus (acid reflux).

By reducing the amount of stomach acid Mac Excellenta can heal the damage of the oesophagus and
relieve symptoms that can happen with the above condition and stop them from coming back.

2. What you need to know before you take Mac Excellenta
Do not take Mac Excellenta if you are:
– allergic to dexlansoprazole or any of the other ingredients of this medicine (listed in section 6 ).
– taking a medicine containing the active substance atazanavir or nelfinavir (used in the treatment of
HIV).

Warnings and precautions
Talk to your doctor before taking Mac Excellenta if you:
– have liver problems. Your doctor may have to adjust your dosage.
– have stomach problems. Your doctor may perform an additional investigation called an endoscopy (where a very
small camera is inserted down your oesophagus to look into your stomach), which can help to exclude more serious
causes of your symptoms.
– take a proton pump inhibitor like Mac Excellenta, especially over a period of more than one year, may slightly
increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you
are taking corticosteroids (which can increase the risk of osteoporosis).
– take Mac Excellenta on a long-term basis (longer than 1 year). Your doctor will probably ask to see you
regularly so he can check how well you are doing. Tell your doctor if you notice any new symptoms or if any of
your symptoms are getting worse.
– take other medicines such as digoxin (for the treatment of heart problems) or diuretics (‘water tablets’).
Your
doctor will probably monitor the magnesium levels in your blood periodically.
Children and adolescents
Do not give this medicine to children or adolescents under 18 years.
Other medicines and Mac Excellenta
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is
because dexlansoprazole can aﬀect the way some other medicines work. Also, some medicines can aﬀect the way
dexlansoprazole works.

Do not take Mac Excellenta if you are taking a medicine containing the active substance atazanavir or nelfinavir
(used in the treatment of HIV).
Check with your doctor before taking Mac Excellenta if you are taking any of the following medicines:
– ketoconazole, itraconazole, rifampicin (to treat infections)
– erlotinib (to treat cancer)
– digoxin (to treat heart problems)
– tacrolimus (to prevent transplant rejection)
– ﬂuvoxamine (to treat depression and other psychiatric diseases)
– warfarin (to prevent thrombosis)
– antacids (to treat heartburn or acid regurgitation)
– sucralfate (for healing ulcers)
– St John’s wort (Hypericum perforatum) (to treat mild depression)
– methotrexate (to treat cancer)
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor for advice before taking this medicine.
Driving and using machines
Side eﬀects such as dizziness, vertigo, tiredness and visual disturbances sometimes occur in patients taking Mac
Excellenta. If you experience side eﬀects like these you should take caution as your ability to react may be
decreased.
You alone are responsible to decide if you are in a fit condition to drive a motor vehicle or perform other
tasks that demand increased concentration. Because of their eﬀects or undesirable eﬀects, one of the factors
that can reduce your ability to do these things safely is your use of medicines.
Descriptions of these eﬀects can be found in other sections. Read all the information in this leaﬂet for
guidance.
Discuss with your doctor if you are unsure about anything.
Mac Excellenta contains sucrose
Sucrose – if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.

3. How to take Mac Excellenta
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you
are not sure.
Swallow the capsules whole with a glass of water. You can take the capsules with or without food. If you have trouble
swallowing Mac Excellenta capsules whole, you can open the capsules and sprinkle the contents on a tablespoon of apple
purée (such as apple sauce). Be sure to swallow the apple mixture right away. Do not chew the mixture. Do not store for
later use.

The recommended dose is as follows:
– Treatment of erosive reﬂux oesophagitis: take 60 mg once daily for 4 weeks. Your doctor may prescribe an
additional 4 weeks.
– Maintenance of healed erosive reﬂux oesophagitis and maintenance of relief of heartburn in patients where
prolonged acid suppression is needed: take 30 mg once daily for up to 6 months.
-Treatment of heartburn and acid regurgitation associated with symptomatic non-erosive gastro- oesophageal reﬂux
disease (GORD): take 30 mg once daily for up to 4 weeks.

Elderly and patients with liver problems: Your doctor may prescribe a lower dose. Your doctor will advise you
how long to take Mac Excellenta.
If necessary your doctor may tell you to take a diﬀerent dose.
If you take more Mac Excellenta than you should
If you accidentally take multiple capsules (overdose), or if someone else takes multiple doses of your medicine
at the same time, talk to a doctor immediately.
The following symptoms have been reported in patients who had taken large doses of dexlansoprazole:
– high blood pressure, hot ﬂushes, bruises, throat pain and weight loss.
If you forget to take Mac Excellenta
If you forget to take a dose, take it as soon as you remember unless it is nearly time for your next dose. If
this happens, skip the missed dose and carry on with your next dose as normal. Do not take a double dose to make
up for a forgotten dose.
If you stop taking Mac Excellenta
Do not stop treatment early because you feel better. Your condition may not have been fully resolved and may
return if you do not finish your course of treatment. Talk to your doctor before stopping this treatment.

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

4.Possible side eﬀects
Like all medicines, this medicine can cause side eﬀects, although not everybody gets them. In clinical studies side
eﬀects associated with Mac Excellenta treatment were mostly mild or moderate.

If you get any of the following side eﬀects, stop taking these capsules and tell your doctor immediately, or contact the
casualty department at your nearest hospital:
– hypersensitivity or serious allergic reactions (frequency not known) such as rash, face swelling, throat tightness,
difficulty breathing
– anaphylactic shock or serious, severe and sudden allergic reaction (frequency not known) with symptoms such as
shortness of breath, confusion, pale colour, severe skin eruptions, throat tightness, weakness, gasping for air and
unconsciousness

The most frequently reported side effects (common – may affect up to 1 in 10 people) were:
– diarrhoea, abdominal pain, headache, feeling sick (nausea), abdominal discomfort, gas (ﬂatulence) and
constipation.
Some patients experienced the following other side eﬀects with Mac Excellenta: Uncommon (may aﬀect up to 1 in
100 people):

– difficulty in sleeping
– depression
– dizziness
– altered taste
– high blood pressure
– hot ﬂushes
– cough
– vomiting
– dry mouth
– liver function test abnormalities
– hives
– itching
– rash
– feeling of weakness
– appetite changes
– fracture of hip, wrist or spine
Rare (may aﬀect up to 1 in 1,000 people):
– hallucinations involving the hearing of voices or sounds
– convulsion
– tingling or numbness
– visual disturbance
– feeling of dizziness or “spinning”
– yeast infections
Not known (frequency cannot be estimated from the available data):
– reduced number of red blood cells. This may cause paleness, weakness, intolerance to physical activity,
dizziness, tiredness and confusion
– bruising or bleeding caused by abnormally low platelet count of unknown cause
– severe skin reactions
– blurred vision
– deafness
– hepatitis caused by medicines (with symptoms such as loss of appetite, headache, nausea, fatigue, fever,
jaundice, pale or clay-coloured stools, dark urine)
– If you are on Mac Excellenta for more than three months it is possible that the levels of magnesium in your
blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation,
convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor
promptly. Low levels of magnesium can lead to a reduction in potassium or calcium levels in the blood. Your
doctor may decide to perform regular blood tests to monitor your levels of magnesium.

5. How to Store Mac Excellenta
All medicine must be maintained out of reach of children Store below 30°C. Protect from light and moisture.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Mac Excellenta contains
– The active substance is dexlansoprazole. Each modified-release capsule contains 60 mg of dexlansoprazole.

Presentation:

14 capsules in a pack