Label: Information for the User

Zeninas Coated Tablets

Powder ofAloe ferox(Aloe)/Extract ofRhamnus purshianusD.C(Senna)

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

• Keep this label, as you may need to read it again.
• If you need advice or more information, consult your pharmacist. If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 4 days.

6.Contents of the Container and Additional Information

Zeninas coated tablets are a stimulant laxative. Laxative effects are produced by an increase in colon movement and stimulation of the processes of fluid secretion, promoting the evacuation of feces.

Zeninas coated tablets are a plant-based medication for the treatment of occasional constipation.

You should consult a doctor if it worsens or does not improve after 4 days.

Do not take Zeninas coated tablets

• If you are allergic (hypersensitive) to Aloe of the Cape (Aloe ferox), to Senna (Rhamnus purshiamus) or to any of the other components of this medication(listed in section 6).
• If you have appendicitis or symptoms of appendicitis such as nausea, vomiting, cramps or abdominal pain.
• If you have intestinal problems such as: undiagnosed rectal bleeding, intestinal obstruction, hemorrhoids; inflammatory abdominal disease (such as Crohn's disease and ulcerative colitis); intestinal atony; and in severe states of dehydration with reduced water and electrolytes.
• If you have severe liver or kidney disease.
• If you have congestive heart failure (the heart does not pump enough blood).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zeninas coated tablets.

• Do not take more doses than indicated in section 3 “How to take Zeninas coated tablets”.
• Before using laxatives for the treatment of constipation, a treatment with high-fiber foods or concentrated fiber should be tried.
• Prolonged use of laxatives should be avoided. If constipation or irregular bowel movements persist for more than four days, the clinical situation should be examined. Prolonged treatments can cause tolerance (habituation) to the laxative effect and dependence (need) on it to achieve evacuation, as well as disturbances in water and electrolyte metabolism.

If this medication is administered to dependent patients, they should perform frequent diaper changes to avoid prolonged contact with feces.

Use of other medications and Zeninas coated tablets

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication, including those obtained without a prescription.

Patients undergoing treatment with cardiac glycosides, antiarrhythmics, medications that prolong the QT curve (quinidine), diuretics(medications that facilitate and increase urine elimination)or licorice root,antibiotics (used to treat infections), medications for treating stomach acid (antacids) such as cimetidine, famotidine, and ranitidine, Potassium supplements. Indomethacin, acetylsalicylic acid, and other inhibitors of prostaglandin synthesis,should consult their doctor before taking this medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

This preparation is eliminated in small amounts through breast milk and although there are no data on the possible laxative effects they may have on infants, it is not recommended for use in these circumstances.

Driving and operating machines

No effects on the ability to drive or operate machines have been described at the recommended doses.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 12 years: 1 coated tablet per day.

Use in children

Do not use this medication in children under 12 years.

Use in people over 65 years

People of advanced age should not take this medication without consulting their doctor, as they are more prone to experiencing adverse effects.

Administration form

This medication is administered orally.

Zeninas coated tablets should be taken with a glass of water, one hour after dinner, preferably before going to bed; the laxative effect will generally be observed the next morning.

• Take the medication with meals or with milk, especially if digestive discomfort is noted. Do not take this medication on an empty stomach.

If constipation persists for more than 4 days, or if symptoms worsen or new ones appear, discontinue treatment and consult a doctor.

If you take more Zeninas coated tablets than you should

If you have taken more Zeninas coated tablets than you should, consult your doctor or pharmacist immediately. The main symptoms of overdose are: massive diarrhea with loss of water and salts.

Severe cases may produce confusion, cardiac arrhythmia, cramps, fatigue, or weakness, which may be more pronounced in older people.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Zeninas coated tablets

Do not take a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The medication's adverse effects are mild and transient.

Discomforts, digestive and gastrointestinal issues, abdominal pains, colic-like pains, belching, and intestinal cramps may appear. Urine may turn a pink-yellow to brown color, which is insignificant and due to the elimination of the medication's components.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any other adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special conservation conditions

Do not use Zeninas coated tablets if you observe any sign of deterioration in the inner packaging that contains the coated tablets.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Zeninas coated tablets

• The active principles are:
• • Powder ofAloe ferox(Aloe): approximately 51.72 mg- 92.59 mg (equivalent to 15 mg of hydroxyanthracenic heterosides).
  • Dried standardized extract ofRhamnus purshianusD.C (Cascara sagrada): approximately 60 mg - 78.95 mg (equivalent to 15 mg of hydroxyanthracenic heterosides). DER (4-6:1). Ethanol 60% v/v.

• The other components (excipients) are:

Core: regalíz, microcrystalline cellulose, sodium croscarmellose, colloidal silica, magnesium stearate, and purified water.

Coating:Vivacoat PA, which contains hypromellose, polydextrose, talc, red iron oxide, black ferric-ferric oxide, titanium dioxide, polyethylene glycol 3350, yellow iron oxide, and indigotina DYE.

Appearance of the product and contents of the packaging

Brown, round, and convex coated tablet.

Presented in formats of 30 coated tablets conditioned in blister packs of PVC/PVDC/AL.

Holder of the marketing authorization

Vemedia Manufacturing B.V.Verrijn Stuartweg 60

NL-1112 AX Diemen

Netherlands

Local representative:

Vemedia Pharma Hispania S.A.

C/Aragón 182 5th floor

08011 Barcelona

Spain

Responsible for manufacturing

Vemedia Manufacturing B.V.Verrijn Stuartweg 60

NL-1112 AX Diemen

Netherlands

Laboratorium Sanitatis, S.L.

Parque Tecnológico de Álava

Leonardo Da Vinci, 11

E-01510 Miñano – Araba / Álava (Spain)

This leaflet was approved in September 2020

Last review date of this leaflet:

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/