Prospecto:Information for the User

Tolterodine Macleods 2 mg Extended-Release Hard Capsules EFG

Tolterodine Macleods 4 mg Extended-Release Hard Capsules EFG

Tartrate of Tolterodine

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctor or pharmacist.
• This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you, as it may harm them.
• If you experience any adverse effects,consult your doctor or pharmacist,evenif they do not appear in this prospectus. See section 4.

1.What is Tolterodine Macleods and for what it is used

2.What you need to knowbeforestarting totake Tolterodine Macleods

3.How to take Tolterodine Macleods

4.Possible adverse effects

5Storage of Tolterodine Macleods

6.Contents of the package and additional information

The active ingredient of this medication is tolterodina.

Tolterodina belongs to a group of medications called antimuscarinics.

This medication is used for the treatment of symptoms of overactive bladder syndrome. If you have overactive bladder syndrome, you may notice that:

• You are unable to control urination voluntarily,
• You feel a sudden and urgent need to urinate without prior warning and/or that you increase the number of times you urinate.

Do not take Tolterodina Macleods:

• if you are allergic to tolterodina or any of the other ingredients of this medication (listed in section 6).
• if you are unable to urinate from the bladder (urinary retention).
• if you have uncontrolled narrow-angle glaucoma (high intraocular pressure with loss of visual field, not being adequately treated)
• if you have myasthenia gravis (excessive muscle weakness)
• if you have severe ulcerative colitis (colon ulceration and inflammation)
• if you have toxic megacolon (acute dilation of the colon)

Warnings and precautions

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

• you have difficulty urinating and/or urinating with a weak or slow flow
• you have a gastrointestinal disorder that affects the passage and/or digestion of food
• you have kidney problems (renal insufficiency)
• you have liver disease
• you have disorders of the nervous system that affect your blood pressure, intestinal function, or sex (any autonomic nervous system neuropathy)
• you have hiatal hernia (hernia in an abdominal organ)
• you have noticed a decrease in intestinal movement or have severe constipation (decreased gastrointestinal motility)
• you have any heart disease such as:
• • abnormal heart rhythm (electrocardiogram)
  • slow heart rate (bradycardia)
  • previous relevant heart diseases such as:
  • • cardiomyopathy (heart muscle weakness)
    • myocardial ischemia (decreased blood flow to the heart)
    • arrhythmia (alteration of heart rhythm)
    • heart failure
• you have abnormally low levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia) in your blood

Consult your doctor or pharmacist before starting treatment with this medication if you think you may have any of these conditions.

Children and adolescents

This medication is not recommended for children.

Other medications and Tolterodina Macleods

Inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medication.

The active ingredient of this medication, tolterodina, may interact with other medications.

This medication should not be used in combination with:

• some antibiotics (containing e.g. erythromycin and clarithromycin)
• medications used to treat fungal infections (containing e.g. ketoconazole and itraconazole)
• medications used to treat HIV.

This medication should be used with caution when administered in combination with:

• some medications that affect food transit (containing e.g. metoclopramide and cisapride)
• medications used to treat irregular heart rhythm (containing e.g. amiodarone, sotalol, quinidine, and procainamide)
• other medications with a similar mode of action to this medication (antimuscarinic properties) or medications with an opposite mode of action to this medication (cholinergic properties). Consult your doctor if unsure.

Use of Tolterodina Macleods with food and drinks

This medication can be taken before, during, or after meals.

Pregnancy and breastfeeding

Pregnancy

This medication is not recommended during pregnancy.If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Breastfeeding

The active ingredient of this medication, tolterodina, is unknown to be excreted in breast milk. It is not recommended to breastfeed while taking this medication.

Driving and operating machinery

This medication may make you feel dizzy, tired, or affect your vision; your ability to drive or operate machinery may be affected.

Tolterodina Macleods contains saccharose

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. Patients with hereditary fructose intolerance (IHF), glucose absorption problems, or saccharose-isomaltose insufficiency should not take this medication.

Dose

Follow exactly the administration instructions for this medication as indicated by your doctor.If in doubt, consult your doctor or pharmacist again.

The recommended dose is one prolonged-release capsule of 4 mg per day, except in patients with liver or kidney disease, or in cases of bothersome side effects, in which case your doctor may reduce your dose to one 2 mg capsule per day.

This medication is not recommended for use in children.

Prolonged-release capsules are taken orally and should be swallowed whole. Do not chew the capsules.

Treatment Duration

Your doctor will indicate the duration of your treatment with this medication. Do not stop treatment prematurely if you do not see an immediate effect, as your bladder needs time to adapt. Complete the treatment with the prescribed prolonged-release capsules. If you do not notice any effect, consult your doctor.

The benefit of treatment should be reevaluated after 2-3 months of use.

Always consult your doctor if you are thinking of stopping treatment

If you take more Tolterodina Macleods than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Tolterodina Macleods

If you forget to take a dose at the usual time, take it as soon as you remember. However, if it is almost time for your next dose, wait until the next scheduled dose and take it at the usual time. In this case, continue taking the capsules as directed by your doctor.

Do not take a double dose to make up for missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

You should consult your doctor immediately if you notice symptoms of angioedema such as:

?Swelling of the face, tongue, or throat.

?Difficulty swallowing.

?Urticaria and difficulty breathing.

In addition, you should seek medical attention if you experience an allergic reaction (for example, itching, rash, urticaria, and difficulty breathing). This occurs with low frequency (may affect up to 1 in 100 people).

Inform your doctor or go to the emergency service if you experience:

Dyspnea, chest pain, or fatigue (even at rest), difficulty breathing at night, swelling of the legs.

These may be symptoms of heart failure. This occurs with low frequency (may affect up to 1 in 100 people).

The following side effects have been observed during treatment with this medicine with the following frequencies.

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

?Dry mouth.

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

?Sinusitis.

?Dizziness, somnolence, headache.

?Dry eyes, blurred vision.

?Difficulty digesting (dyspepsia), constipation, abdominal pain, excessive amount of air or gas in the stomach or intestines.

?Pain or difficulty urinating.

?Fatigue.

?Swelling due to fluid accumulation (e.g., in the ankles).

?Diarrhea.

Rare side effects(may affect up to 1 in 100 people) are:

?Allergic reactions.

?Nervousness.

?Sensation of tingling in the fingers of the hands and feet.

?Dizziness.

?Palpitations, heart failure, irregular heartbeat.

?Inability to empty the bladder.

?Chest pain.

?Memory alteration.

Additional reported reactions include severe allergic reactions, confusion, hallucinations, increased heart rate, red skin, stomach burning, vomiting, angioedema, and dry skin and disorientation. Cases of worsening of dementia symptoms in patients being treated for dementia have been reported.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not described in this prospectus, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not appearing in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe boxafter “EXP.:”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and unused medications. In this way, you will help protect the environment.

Tolterodine Macleods Composition

The active ingredient is tolterodine tartrate

2 mg:Each prolonged-release capsule contains 2 mg of tolterodine tartrate corresponding to 1.37 mg of tolterodine.

4 mg:Each prolonged-release capsule contains 4 mg of tolterodine tartrate corresponding to 2.74 mg of tolterodine.

The other components are:

Caplet content: sugar granules (containing sucrose and cornstarch), hydroxypropylmethylcellulose, talc, ethylcellulose type B dispersion.

Capsule: gelatin and sodium lauryl sulfate

Colorants:

2 mg: Yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171) Blue FD & C (E133)

4 mg: Red iron oxide (E172), titanium dioxide (E171) Blue FD & C (E133)

Printing ink: Shellac lacquer (E904),anhydrous ethanol (E1510),isopropyl alcohol, butanol, propylene glycol (E1520), ammonium hydroxide (E527), potassium hydroxide (E525), titanium dioxide (E171).

Product appearance and packaging content

This medication is a prolonged-release capsule designed for once-daily administration.

2 mg: Blue-green cap / blue-green body size “4”. The capsule contains white-yellowish prolonged-release pelets with ‘L32’ on the cap and ‘2’ on the body printed in white ink.

4 mg: Blue cap / blue body size “3”. The capsule contains white-yellowish prolonged-release pelets with ‘L33’ on the cap and ‘4’ on the body printed in white ink.

This 2 mg and 4 mg prolonged-release capsule medication is available in the following packaging sizes:

Pouch blisters in cold form: The blister pack is composed of aluminum foil and cold laminated.

Pouches containing 28, 49, 50, 56, 98 capsules.

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Macleods Pharma España S.L.U.

World Trade Center Barcelona

Moll de Barcelona, s/n,

08039 Barcelona, Spain

Responsible manufacturer

Macleods Pharma UK Limited

Wynyard Park House,

Wynyard Avenue,

Wynyard, Billingham,

TS22 5TB,

United Kingdom

Or

Heumann Pharma GmbH & Co.Generica KG

Südwestpark 50

90449 Nürnberg

Germany

Or

Synoptis Industrial SP.Z.O.O.

ul. Rabowicka 15

62020 Swarzedz

Poland

Last review date of thisleaflet:April 2018

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)